Slide 1: Neural Stem Cell Technology Platform: Cell Therapy and Pharmaceuticals
Neural Stem Cell Technology Platform Cell Therapy and Pharmaceuticals NYSE Amex: CUR
Slide 2: Safe Harbor Statement
2 NEURALSTEM, INC. SAFE HARBOR STATEMENT This presentation contains forward - looking statements. Neuralstem wishes to caution the readers of and listeners participating in this presentation that actual results may differ from those discussed in the forward - looking statements and may be adversely
Slide 3: Neuralstem 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 □ Patented □ Issued and re - affirmed worldwide □ Fully characterized □ Expanded under defined conditions: no animal - derived reagents, serum
Slide 4: The Promise of Stem Cell Therapeutics Years in the Making
Neuralstem, Inc. The Promise of Stem Cell Therapeutics 15 Years in the Making □ Cell manufacturing: cGMP □ FDA approved for human trials □ Phase I Human Trials □ Cells – Safe □ Procedure – Safe □ ALS – First 12 patients completed □ Drug screening – resulting in new class of compounds: patented and i
Slide 5: Global Clinical Trial and Product Status Overview
Neuralstem, Inc. Global Clinical Trial and Product Status Overview □ U.S. FDA - approved Trials to Date □ Cell Therapy □ ALS: Phase I commenced Jan. 2010; 12 patients transplanted to date □ Orphan status designation awarded by the FDA in Nov. 2010 □ Pharmaceuticals □ Major Depression: Phase Ia for N
Slide 6: ALS Trial: World-Class Trial Design and Execution
U.S. Neuralstem ALS Trial World - Class Trial Design and Execution □ Principal Investigator: Eva L. Feldman, M.D., Ph.D. , Professor of Neurology & Director A. Alfred Taubman Medical Research Institute of the University of Michigan Medical School □ Site Principal Investigator: Jonathan D. Glass, M.D
Slide 7: ALS Trial Data Collection
U.S. Neuralstem Cell Therapeutics ALS Trial Data Collection □ 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 au
Slide 8: Chronic Spinal Cord Injury (cSCI) – Second Application
U.S. Neuralstem Cell Therapeutics Chronic Spinal Cord Injury (cSCI) – Second Application □ Product status: IND filed August 2010 for Phase I Safety Clinical Trial; pending additional safety data □ Similarity to ALS product: Same cells, same injection procedure as ALS trial □ Mechanism of Action : Re
Slide 9: Chronic Motor Disorders from Stroke – Next Indication
U.S. Neuralstem Cell Therapeutics Chronic Motor Disorders from Stroke – Next Indication □ Product status: IND to be filed 2011 for Phase I Safety Clinical Trial □ Mechanism of Action : Neural plasticity and regeneration □ Route of Administration : Intracerebral injections at peri - infarct sites – m
Slide 10: Brain Cancer – U.S. Department of Defense Contract
U.S. Neuralstem Cell Therapeutics Brain Cancer – U.S. Department of Defense Contract □ Product Research status : Neuralstem’s first anti - cancer cell therapeutics program □ Product Funding: DOD contract to develop and engineer neural stem cell technology for the treatment of brain cancer □ Contract
Slide 11: International Neuralstem Program Advances Cell Therapeutics' Product Status
International Neuralstem Program Advances Cell Therapeutics’ Product Status □ Neuralstem China : Stroke – Trial expected to commence in late 2011/early 2012 □ Wholly owned subsidiary: Neuralstem China 神脑生物医药公司 (Suzhou Neuralstem Biopharmaceutical Company, Ltd.) □ BaYi Brain Hospital in Beijing, coll
Slide 12: Small Molecule Drug Program – A New Class of Drugs
Neuralstem Pharmaceuticals Small Molecule Drug Program – A New Class of Drugs □ U.S. DOD - funded screening platform viability demonstration and the discovery of the class of drugs □ Patents issued for these new neurogenic small molecule drugs (f irst issued 2008) □ Neuralstem owns 100% of the comme
Slide 13: Neurogenic Small Molecule Drug Program: NSI-189
U.S. Neuralstem Pharmaceuticals Neurogenic S mall Molecule Drug Program □ NSI - 189 □ First in this new class of compounds □ Characteristics: molecular wt. <400, orally active, excellent brain penetration, key biological activity: enhanced neurogenesis and increased hippocampal volume □ Major Depres
Slide 14: Business Strategy: Pharmaceuticals and Cell Therapy
Business Strategy Pharmaceuticals and Cell Therapy □ Pharmaceuticals □ Take NSI - 189 through at least Phase II human trial before licensing out – except for Japanese market □ Japan : Retained Sumitomo’s Summit Pharmaceuticals International Corporation – early stage partnership □ Ib data licensing a
Slide 15: 2011 Catalysts
Neuralstem, Inc. 2011 Catalysts □ Current Trials □ ALS lumbar - transplantations conclusion; cervical - transplantations commencement and completion of enrollment □ ALS Orphan Status Designation from FDA □ NSI - 189, Major Depression, Phase Ia Trial completion; approval and dosing of Ib Trial □ Tria