Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Investor Presentation (September 2013)
22 slides from Palisade Bio's investor presentation, Sep 10, 2013
Slide 1: World Leader in Neural Stem Cell Science Corporate Overview
World Leader in Neural Stem Cell Science Corporate Overview September 2013
Slide 2: Safe Harbor Statements
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: 12-Month Clinical Trial Catalysts
1 2 - Month Clinical Trial Catalysts NSI - 566/ALS • Phase II U.S. Trial • FDA - approved trial commenced September 2013 • NIH - major funding • Increased dosing, all cervical • Dual center, accelerated timeline • Data 6 mos. after final surgery • Orphan Status Designation • Est. 30,000 ALS patients
Slide 4: Neuralstem Technology – Cells Nurturing, Supporting and Rescuing Remaining Neurons
Neuralstem Technology – Cells Nurturing, Supporting and Rescuing Remaining Neurons • Regionally specific CNS neural stem cells: brain and spinal cord • 14 U.S. p atents re - affirmed worldwide, 8 pending • cGMP manufacturing • Numerous cell therapy stem cell products • Fully characterized • Expanded
Slide 5: Single Platform Technology, Two Programs, Multiple Indications
Single Platform Technology, Two Programs, Multiple Indications Ischemic Spastic Paraplegia Amyotrophic Lateral Sclerosis Optic Neuritis Lysosomal Diseases Ischemic Stroke Alzheimer’s Disease Parkinson’s Disease Spinal Cord Injury Traumatic Brain Injury Huntington’s Disease Glioblastoma (Brain Cancer
Slide 6: Human Proof of Concept, Safety, and Signs of Efficacy
NSI - 566 Human Proof of Concept, Safety, and Signs of Efficacy • First Application: ALS – Amyotrophic Lateral Sclerosis • No Cure, progressive neurodegenerative disease • NSI - 566 FDA Orphan Designation • Market: Unmet Medical Need: • Est. 30,000 U.S., with est. 5,600+ diagnoses per year (ALSA) •
Slide 7: 566/ALS Phase I Success: Proven Safe, Signs of Efficacy
NSI - 566/ALS Phase I Success: Proven Safe, Signs of Efficacy Five of six ambulatory patients showed improvement or very slow progression of the disease post surgery Nonambulatory Cohorts ( Patients 1 - 6) Ambulatory Cohorts (Patients 7 – 12 ) ALS Functional Rating Scale – Revised ( ALSFRS - R) moni
Slide 8: 566/ALS – FDA-Approved Phase II: Increase Dosage, Evaluate Efficacy and Safety
NSI - 566/ALS – FDA - Approved Phase II: Increase Dosage, Evaluate Efficacy and Safety • U.S. Phase II Commenced in September of 2013 • Emory announced significant NIH grant to cover majority of Phase II trial cost • Collaborators : Eva L. Feldman, M.D., Ph.D. and Jonathan D. Glass, M.D. • Goal: max
Slide 9: 566/Spinal Cord Injury Trials – Same Cells and Procedure
NSI - 566/Spinal Cord Injury Trials – Same Cells and Procedure • Market: Unmet Medical Need: • Est. 840,000 SCI patients, with 10,000 + new spinal cord injuries per year, U.S . ( NSCIA) • 85 % of SCI patients who survive first 24 hours are alive ten years later (NSCIA ) • U.S. - NSI - 566/ cSCI Phas
Slide 10: 566/Ischemic Stroke – Rebuilding Neural Circuitry and Promoting Repair
NSI - 566/Ischemic Stroke – Rebuilding Neural Circuitry and Promoting Repair and Recovery of Surviving Tissue • Market: Unmet Medical Need • Est. 7,000,000 have survived a stroke, U.S. ( NSA); est. 1,750,000 people in China, per year, survive a stroke • 87 % of stroke cases are ischemic stroke (ASA,
Slide 11: 566/ALS Completed Phase I Data Propels Additional Trials
NSI - 566/ALS Completed Phase I Data Propels Additional Trials Development Pipeline – Clinical Trials Status 17 Development Phase I Phase II Phase III ALS U.S. FDA - approved t rial commenced Sept 2013 ALS Mexico Combined Phase I/II cSCI U.S. FDA - approved trial , e xpect to initiate Phase I in 2 n
Slide 12: First-in-class Neurogenic Small Molecule Drugs – Reverse Hippocampal Atrophy
First - in - class Neurogenic Small Molecule Drugs – Reverse Hippocampal Atrophy • “War Fighter of the Future” DOD program, initial funding • Patented Novel Neurogenic Compounds • 100% owned for commercialization • Early mover advantage • Recruit endogenous neural stem cells to generate more new neu
Slide 13: First Application: Major Depressive Disorder – Phase Ib
NSI - 189 First Application: Major Depressive Disorder – Phase Ib Completion and Data Expected 2 nd Half of 2013 • Market: Challenging Medical Need: • Est . 14.8 million adults, and leading cause of disability, U.S . for ages 15 - 44 (NIMH) • New theory of how to t reat: Brain physiology in the dise
Slide 14: 189/MDD – Next Phase: Development Partnering
NSI - 189/MDD – Next Phase: Development Partnering • Development Partner • Actively pursuing partnership for large - scale NSI - 189 ramp - up expected in 2013 • Phase II, III, and commercialization: MDD, broad range of psychiatric and cognitive disorders • Locust Walk Partners: life sciences’ comme
Slide 15: Neuralstem – Strengths and Future Value Drivers
Neuralstem – Strengths and Future Value Drivers 22 Scientific Strength, Out In Front • Leader: neural stem cell science • Repeated firsts in both divisions, including FDA approval: ◦ ALS & SCI cell therapy trials ◦ MDD lead novel neurogenic compound • Technology platform R&D developed at NIH • Broad
Slide 16: Appendix
Appendix • Management • Patents: Technology and Products • Proprietary Surgical Devices: Cell Therapy • Published Papers • World - Class Clinical Partners 17
Slide 17: Management: Dedicated, Driven Team
Management: Dedicated, Driven Team Karl Johe , Ph.D., Chairman of the Board and Chief Scientific Officer • Discovered and developed human neural stem cell technology, while at NIH • Successful neural stem cell therapy is career - long goal • Early work for four years as staff scientist at the NIH La
Slide 18: Technology & Product U.S. Patents Issued and Reaffirmed Worldwide
Technology & Product U.S . Patents Issued and Reaffirmed Worldwide • U. S. Notice of Allowance for Patent Application 12/404,841 (April 2013) • Methods for treating ALS with expanded spinal cord stem cells • U . S. Pat. No. 8,362,262 (January 2013) • Small Molecule: divisional compositions and metho
Slide 19: Exclusive Worldwide Licenses: Breakthrough Cell Therapy Surgical Devices
Exclusive Worldwide Licenses: Breakthrough Cell Therapy Surgical Devices • Spinal Platform and Floating Cannula • Proprietary breakthrough medical devices proven safe in 18 surgeries • New standard in industry and research community for intraspinal procedures • Designed by ALS trial neurosurgeon, Ni
Slide 20: Published Papers
Published Papers • Amelioration of motor/sensory dysfunction and spasticity in a rat model of acute lumbar spinal cord injury by human neural stem cell transplantation. • Sebastiaan van Gorp , Marjolein Leerink , Osamu Kakinohana , Oleksandr Platoshyn , Camila Santucci , Jan Galik , Elbert A. Jooste
Slide 21: World-Class Clinical Partners
World - Class Clinical P artners • NSI - 566/ALS Trial Clinical Investigators: • Principal Investigator: Eva L. Feldman, M.D., Ph.D., Professor of Neurology & Director A. Alfred Taubman Medical Research Inst. of the University of Michigan Medical School; President of American Neurological Assn. • Si
Slide 22: World Leader in Neural Stem Cell Science
World Leader in Neural Stem Cell Science neuralstem.com