Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Investor Presentation (February 2013)
29 slides from Palisade Bio's investor presentation, Feb 15, 2013
Slide 1: World Leader in Neural Stem Cell Science Corporate Overview
World Leader in Neural Stem Cell Science Corporate Overview February 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: Overview
Overview Industry Firsts • Inventor of human neural stem cell technology is Karl Johe , Ph.D., Chairman and Chief Scientific Officer, while at NIH • First FDA - approved neural stem cell therapy trials for ALS & chronic spinal cord injury • First - in - class hippocampal neurogenic small molecule dr
Slide 4: 12-Month Clinical Trial Catalysts
1 2 - Month Clinical Trial Catalysts NSI - 566/ALS • Phase II U.S. Trial • NIH - major funding • Increased dosing, all cervical • Dual center, accelerated timeline • Data 6 months after final surgery • Orphan Status Designation • Est. 30,000 ALS patients, est. 5,600 diagnosed per year, U.S. • Phase
Slide 5: 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 • 9 U.S. p atents re - affirmed worldwide, 22 pending • cGMP manufacturing • Numerous cell therapy stem cell products • Fully characterized • Expanded
Slide 6: 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 7: NSI-566 Human Proof of Concept, Safety, and Signs of Efficacy
NSI - 566 Human Proof of Concept, Safety, and Signs of Efficacy • Successful , safe injection of neural stem cells • 15 patients, 18 surgeries • L umbar and/or cervical regions of spinal cords • No complications related to cell delivery • No toxicity related to cells • Definitive evidence of long -
Slide 8: ALS – Amyotrophic Lateral Sclerosis
ALS – Amyotrophic Lateral Sclerosis • NSI - 566 FDA Orphan Designation • No C ure • Unmet Medical Need: • Est. 30,000 Americans have disease at any given time (ALSA) • Est. 5,600+ people diagnosed each year in the U.S. (ALSA) • Est. n early 120,000 cases diagnosed worldwide each year (Int’l Alliance
Slide 9: NSI-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 6 – 12 ) ALS Functional Rating Scale – Revised ( ALSFRS - R) moni
Slide 10: Neuralstem ALS Patient Story: Ted Herada
Neuralstem ALS Patient Story: TED HERADA - Patient 12 Surgery #12 (lumbar) - Reversed ALS Progression • 39 years old, ALS diagnosed 2009 • 1 st treatment March 2011 – lumbar (lower spinal cord) • 10 injections, bilateral, 100,000 cells per • 4 - hour procedure, therapy well - tolerated • Walking wit
Slide 11: NSI-566/ALS Next Phase: Increase Dosage, Evaluate Efficacy and Safety
NSI - 566/ALS - Next Phase: Increase Dosage, Evaluate Efficacy and Safety • U.S. Phase II expected to commence in second half of 2013 • Emory announced significant NIH grant to cover majority of Phase II trial cost • Pending FDA approval of new protocol; IND filed 4Q12; official Phase I completion d
Slide 12: Spinal Cord Injury – Neuralstem Cells To Bridge the Gap
Spinal Cord Injury – Neuralstem Cells To “Bridge the Gap” • Unmet Medical Need: • Approximately 840,000 SCI patients in the U.S. (NSCIA) • 10,000+ new spinal cord injuries each year in the U.S. (NSCIA) • 85% of SCI patients who survive first 24 hours are alive ten years later (NSCIA) • Affects nerve
Slide 13: NSI-566/SCI Trials – Same Cells and Procedure
NSI - 566/SCI Trials – Same Cells and Procedure • U.S. - NSI - 566/ cSCI Phase I Expected to Commence in 2 nd Half of 2013 • FDA approved trial in January 2013 • One - year Phase I completion goal ; trial study period ends six months post - surgery for each patient • Principal investigator: Keith Ta
Slide 14: Ischemic Stroke
Ischemic Stroke • Stroke is 4 th - leading cause of death in U.S. (NSA) • Stroke is a leading cause of adult disability (NSA) • Unmet Medical Need: • Est. 7,000,000 Americans have survived a stroke (NSA) • Est. 1,750,000 people in China alone, per year, survive a stroke • 87% of stroke cases are isc
Slide 15: NSI-566/Ischemic Stroke – Rebuilding Neural Circuitry
NSI - 566/Ischemic Stroke – Rebuilding Neural Circuitry and Promoting Repair and Recovery of Surviving Tissue • Combined Phase I / II Trial expected to commence in 1Q13 – approved September 2012 • Wholly owned subsidiary: Neuralstem China 神 脑生物医药公司 ( Suzhou Neuralstem Biopharmaceutical Company, Ltd.
Slide 16: NSI-566 Cell Therapy – Additional Applications
NSI - 566 Cell Therapy – Additional Applications • Glioblastoma (Brain Cancer ) • Research program initiated with U.S. DOD funding: $1.6 M award • Preclinical: Developing and Engineering neural stem cell technology to express anti - cancer agents • Collaborator: John H. Zhang, M.D. Ph.D., Loma Linda
Slide 17: NSI-566 Development Pipeline – Clinical Trials Status
NSI - 566/ALS Completed Phase I Data Propels Additional Trials Development Pipeline – Clinical Trials Status 18 Development Phase I Phase II Phase III ALS U.S. IND Sub: Dec 2012 Expect to initiate Phase II in 1Q13 ALS Mexico Combined Phase I/II, pending partnership agreement cSCI U.S. FDA Approval:
Slide 18: 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 • NSI - 189: Lead Compound • R ecruit endogenous neural stem ce
Slide 19: Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD) • NSI - 189 Lead Drug Candidate First Application • Challenging Medical Need: • Est. 14.8 million American adults (NIMH) • Leading Cause of Disability in U.S. for ages 15 - 44 (NIMH) • New Theory of How To Treat: • Brain physiology in the disease rather than brain che
Slide 20: NSI-189/MDD – Phase Ib Escalated Dosing, Topline Data Expected 2Q13
NSI - 189/MDD – Phase Ib Escalated Dosing, Topline Data Expected 2Q13 • Established drug safety in Phase Ia h ealthy volunteers : 41 volunteers received escalating doses of single oral administration (completed October 2011 ) • Psychiatric clinical trial consultant : Maurizio Fava, M.D., Slater Fami
Slide 21: NSI-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, a life sciences’ co
Slide 22: Neuralstem – Strengths and Future Value Drivers
Neuralstem – Strengths and Future Value Drivers 22 Scientific Strength, Out In Front Leader in neural stem cell science Repeated firsts in both divisions, including FDA approval: ALS and SCI neural stem cell trials & MDD lead novel neurogenic compound Technology platform R&D developed at NIH Broad,
Slide 23: Appendix
Appendix • Management • Patents: Technology and Products • Proprietary Surgical Devices: Cell Therapy • Published Papers • World - Class Clinical Partners 23
Slide 24: 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 25: Technology & Product U.S. Patents Issued and Reaffirmed Worldwide
Technology & Product U.S . Patents Issued and Reaffirmed Worldwide • U. S. Pat. No. 8,236,299 (August 2012) • Transplantation of human neural cells for treatment of neurodegenerative conditions • U.S. Pat. No. 8,058,434 (November 2011) • Compositions to effect neuronal growth • U.S. Pat. No. 8,030,4
Slide 26: 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 27: Published Papers
Published Papers • Long - Distance Growth and Connectivity of Neural Stem Cells after Severe Spinal Cord Injury. • Paul Lu, Yaozhi Wang, Lori Graham, Karla McHale, Mingyong Gao , Di Wu, John Brock, Armin Blesch , Ephron S. Rosenzweig , Leif A. Havton , Binhai Zheng , James M. Conner, Martin Marsala
Slide 28: 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 29: World Leader in Neural Stem Cell Science
World Leader in Neural Stem Cell Science neuralstem.com