Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Investor Presentation (January 2013)
24 slides from Palisade Bio's investor presentation, Jan 9, 2013
Slide 1: Neural Stem Cell Technology Platform: Cell Therapy and Pharmaceuticals
Neural Stem Cell Technology Platform Cell Therapy and Pharmaceuticals January 2013 NYSE MKT: CUR
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: Management
Neuralstem , Inc. Management □ Karl Johe , PhD Chairman of the Board Chief Scientific Officer □ Discoverer and developer of Human Neural Stem Cell Technology □ Staff Scientist at the NIH Laboratory of Molecular Biology of the National Institute of Neurological Disorders and Stroke in Bethesda, 1993
Slide 4: Investment Highlights
Neuralstem , Inc. Investment Highlights □ Proprietary Patented Neural Stem Cell Platform Foundation for Cell Therapy and Small Molecule Programs □ NIH - discovered platform; F ully characterized, regionally specific neural stem cells □ Positive Human Data for Neural Stem Cell Therapy in ALS Patients
Slide 5: Technology: Stem Cells of the Brain and the Spinal Cord
Neuralstem Technology Stem Cells of the Brain and the Spinal Cord □ Platform technology □ Numerous cell therapy products □ Regionally specific CNS stem cells □ cGMP manufacturing □ Patented □ Issued and re - affirmed worldwide □ Fully characterized □ Expanded under defined conditions: no animal - de
Slide 6: Technology: U.S. Patents Issued and Re-affirmed Worldwide
Neuralstem Technology U.S. Patents Issued and Re - affirmed Worldwide □ U. S. Pat. No. 8,236,299 (August 2012) □ Transplantation of human n eural c ells for treatment of neurodegenerative conditions □ U.S . Pat. No. 8,058,434 (November 2011) □ Compositions to effect neuronal growth □ U.S . Pat. No.
Slide 7: Platform Commercialization and Roll-out
Neuralstem Platform Cell Therapeutics’ Commercialization and Platform Roll - out 7 Neuralstem Technology Platform Direct Injection / Transplantation Into the Spinal Cord or Brain Cell Therapy Small Molecule Discovery and Development Enabled by Proprietary Stem Cell - based Screening Pharmaceuticals
Slide 8: ALS Phase I Safety Data: First Patients
Neuralstem ALS Trial ALS Phase I Safety Data: First 18 Patients 8 □ Phase I Data Key Findings □ Successful, safe injection of NSI - 566 neural stem cells into 18 ALS patients in lumbar and/or cervical regions of spinal cords □ No complications related to cell delivery □ No toxicity related to cells
Slide 9: ALS Phase I Clinical Trial: Cervical Phase Timing
Neuralstem Cell Therapy Program (U.S.) ALS Phase I Clinical Trial: Cervical Phase Timing □ Cervical cohort transplantations completed (6 of 6): □ First Cervical Patient #13: Nov. 2011 □ Patient #14: Feb. 2012 □ Patient #15 : April 2012 □ First Returning Patient #16: June 2012 □ Patient #17: July 201
Slide 10: ALS Phase I Disease Progression: ALSFRS-R First 12 Patients
10 Glass, et. al. STEM CELLS 2012;30:1144 – 1151 Neuralstem ALS Trial ALS Phase I Disease Progression: ALSFR - R - First 12 Patients □ The Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised ( ALSFRS - R) is an instrument used by the physician for evaluating the functional status of pati
Slide 11: ALS Phase I Disease Progression: FVC & HHD First 12 Patients
11 Glass, et. al. STEM CELLS 2012;30:1144 – 1151 Neuralstem ALS Trial ALS Phase I Disease Progression: FVC & HHD - First 12 Patients □ Forced Vital Capacity (FVC) is a lung function test that measures total lung capacity by the amount of gas contained in the lung at the end of a maximum inhalation F
Slide 12: Cell Therapy Program (U.S.) Additional Indications
Neuralstem Cell Therapy Program (U.S.) Additional Indications □ Spinal Cord Injury (SCI) □ IND filed August 2010, on hold, expecting release of hold in 1Q13 □ Same cells and injection procedure as ALS trial □ Ischemic Stroke □ Positive proof - of - principle data from rat stroke model (University of
Slide 13: Cell Therapy Program (International) Product Status
Neuralstem Cell Therapy Program (International) Cell Therapy Product Status □ Neuralstem China : Ischemic Stroke □ Phase I / II Trial expected to commence in 1Q13 □ Wholly owned subsidiary: Neuralstem China 神 脑生物医药公司 (Suzhou Neuralstem Biopharmaceutical Company, Ltd.) □ BaYi Brain Hospital in Beijin
Slide 14: Small Molecule Drug Program
Neuralstem Small Molecule Drug Program First - in - class Neurogenic Small Molecule Drugs □ Initially funded by U.S. DOD □ Patented neurogenic small molecule compounds: the ability to recruit endogenous neural stem cells to generate more new neurons in the adult brain □ Lead Drug in Clinical Develop
Slide 15: NSI-189/MDD Small Molecule Phase I Trial Design
Neuralstem NSI - 189/MDD Trial Small Molecule Phase I Trial Design □ Primary Endpoint □ Safety □ Secondary Endpoints □ Tolerability □ Pharmacokinetics □ Pharmacodynamic effects (hippocampal volume by MRI, BDNF/CRH/other factors in blood, urine biomarkers, cortisol in saliva, qEEG , MADRS, NGH Depres
Slide 16: NSI-189/MDD Phase Ib Clinical Trial: Depressed Patients
Neuralstem Small Molecule Drug Program NSI - 189/MDD Phase Ib Clinical Trial: Depressed Patients □ Major Depressive Disorder (MDD) – leading indication □ Phase Ib , 28 - day multiple ascending dose study, commenced June 2012 □ Other potential NSI - 189 applications □ Alzheimer’s Disease □ Cognitive
Slide 17: Clinical Programs Plan for 2012-2013
Neuralstem , Inc. Clinical Programs Plan for 2012 - 2013 17 2011 2012 2013 Cell Therapy Programs ALS (NSI - 566) Spinal Cord Injury (NSI - 566) Ischemic Stroke (NSI - 566) Small Molecule Programs Major Depressive Disorder (NSI - 189) Completed Trials Core U.S. Trials Ex - U.S. Expansion Trials Phase
Slide 18: Catalysts: Next Months
Neuralstem , Inc. Catalysts : Next 12 Months □ Ongoing Clinical Trials □ ALS □ Phase I cervical - transplantations conclusion (final surgery completed: August 2012) □ Phase II trial application □ NSI - 189 □ Phase Ib trial data and completion □ Phase IIa trial application in U.S. □ New Clinical Tria
Slide 19: Summary
Neuralstem , Inc. Summary □ Proprietary Patented Neural Stem Cell Platform Serves as Foundation for Cell Therapy and Small Molecule Programs □ Positive Human Data for Neural Stem Cell Therapy in ALS Patients □ Cell Therapy procedure and NSI - 566 treatment shown to be safe and well - tolerated, with
Slide 20: Appendix
Neuralstem , Inc. Appendix □ ALS Phase I Trial Design □ Cell Therapy Surgical Device □ Published Papers □ World Class Partners 20
Slide 21: ALS Phase I Trial Design
Neuralstem ALS Trial ALS Phase I Trial Design □ Primary Endpoint □ Safety □ Secondary Endpoints □ Attenuation of motor function loss □ Maintenance of respiratory capacity □ Stabilization of ALS functional rating scale □ Reduction of spasticity/rigidity if present □ Graft survival at autopsy upon mor
Slide 22: Cell Therapy Surgical Devices: Exclusive Worldwide Licenses
Neuralstem Cell Therapy Surgical Devices Exclusive Worldwide Licenses □ Spinal Platform and Floating Cannula □ Proprietary breakthrough medical devices □ Expected to be the standard in industry and research community for intraspinal procedures □ Neuralstem holds exclusive worldwide licenses □ Design
Slide 23: Technology: Published Papers
Neuralstem Technology 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. Co
Slide 24: Collaborators: World-Class Clinical Partners
Neuralstem , Inc. Collaborators World - Class Clinical P artners □ 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