Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — The 17th Annual BIO CEO & Investor Conference (February 2015)
17 slides from Palisade Bio's conference presentation, Feb 9, 2015
Slide 1: The 17th Annual BIO CEO & Investor Conference
The 17 th Annual BIO CEO & Investor Conference February 9, 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 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 4: Neuralstem Technology
Neuralstem Technology 4 • Discovered at NIH • Regionally specific CNS neural stem cells: brain and spinal cord • Fully characterized: • Expanded under defined conditions: no animal - derived reagents, serum or feeder cells • Reproducible differentiation: constitutive behavior of cells • FDA cGMP man
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 2Q3Q15 Cell Therapy N
Slide 6: Neurogenic Small Molecule Platform
Neurogenic Small Molecule Platform • Novel mechanisms of action: benefits for depression and cognition • Highly specific and potent effect in the hippocampus the well - known neurogenic region in the adult CNS • First in class: novel neurogenic compound • Key biological activity: » Neurogenesis in t
Slide 7: MDD Phase Ib
NSI - 189 MDD Phase Ib • Only 1/3 of MDD patients achieve full remission with available antidepressants • All current FDA - approved antidepressants affect the monoamine systems • Positive Phase Ib randomized, double - blind, placebo - controlled, dose - escalation; 28 day dosing, 8 week follow - up
Slide 8: MDD Phase Ib depression symptom results (SDQ, MADRS)
• SDQ combined treatment group showed statistically significant improvement (p=0.02) • Clinically meaningful reduction in depressive & cognitive symptoms (40mg, 80mg) • R apid onset of action and persistent efficacy over the non - dosing 8 - week follow - up period • Effect size (d - value) measures
Slide 9: MDD Phase Ib Cognitive and Physical Functioning Questionnaire
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 • S ignificant effect size in cognitive function improvement; improvement persisted over 8 - w
Slide 10: MDD Phase Ib Neurogenic MOA
NSI - 189 MDD Phase Ib Neurogenic MOA Quantitative EEG ( qEEG ) measurements, electrophysical biomarker: • Significantly increased brain wave patterns in the hippocampal region of the brain E lectrophysiological changes are consistent with the neurogenic hypothesis of the drug mechanism , which invo
Slide 11: Pipeline Expansion
NSI - 189 Pipeline Expansion • Phase Ib to commence 2Q/3Q15 • Hippocampal atrophy well documented in this patient population • Psychotic episodes are distinct from cognitive deficit • Cognitive symptoms often make it hard to lead a normal life and can cause great emotional distress • High unmet pati
Slide 12: Cell Therapy Human Proof of Activity, Safety, and Signs of Efficacy
NSI - 566 Cell Therapy Human Proof of Activity, Safety, and Signs of Efficacy Successful , safe injection of neural stem cells • 30 patients, 36 surgeries • Lumbar and/or cervical regions of spinal cords – No toxicity related to cells – Definitive evidence of long - term cell survival via DNA finger
Slide 13: Lead Program: Amyotrophic Lateral Sclerosis
NSI - 566 Lead Program: Amyotrophic Lateral Sclerosis • Phase II ALS Data expected 1Q15 • NIH and ALAS grants covered a majority of Phase II trial costs • NSI - 566 FDA Orphan Designation • Unmet Medical Need: – No existing effective therapy – Est. 30,000 Americans have disease at any given time (AL
Slide 14: 566/ALS Phase I Long Term ALSFRS-R Data
NSI - 566/ALS Phase I Long Term ALSFRS - R Data 14 Phase Ia Patient Follow - up: 1200 day efficacy data • Patients 10, 11, 12, received ten lumbar and five cervical injections of 100,000 cells each • ALSFRS - R data shows patient #11 with functional improvement from pre - treatment baseline • Patien
Slide 15: 566/ALS Phase I Long Term Data
NSI - 566/ALS Phase I Long Term Data – NSI - 566 cells are safe and well tolerated – Lumbar surgeries can be safely and routinely preformed – Long term cell survival and differentiation – Proof of “Activity” - Cells provide neurotrophic support; acting as “ nurse”cells – Long term (1200 day) therape
Slide 16: ALS Phase I/II Clinical Trial
NSI - 566 ALS Phase I/II Clinical Trial - Safe and routine cervical surgery - Maximum tolerated dose: 400,000 cells per injection, 20 injections for each lumbar and cervical surgery - Proof of “activity” from cells providing neurotrophic support - Investigating the ALSFRS - R and subset muscle group
Slide 17: Neuralstem Overview
Neuralstem Overview 17 Expansion NSI - 189 neurogenic small molecule platform Phase Ib cognitive deficit in schizophrenia commence 2Q/3Q15 Phase II MDD commence in 2Q15 Phase Ib data; Dr. Maurizio Fava 1Q/2Q15 NSI - 566 cell therapy platform Phase II ALS data 1Q15 Phase IIb ALS expected commencement
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