Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — IPO Roadshow (July 2019)
24 slides from Palisade Bio's IPO roadshow presentation, Jul 22, 2019
Slide 1: A New Beginning
A New Beginning neuralstem.com Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Dated July 22, 2019 Registration Statement No. 333 - 232273 Relating to Preliminary Prospectus Dated July 22, 2019
Slide 2: Free Writing Prospectus
neuralstem.com Free Writing Prospectus 2 This free writing prospectus relates to the offering of ( i ) shares of common stock and warrants to purchase shares of common stock and (ii) pre - funded warrants to purchase shares of common stock and warrants to purchase shares of common stock of Neuralste
Slide 3: Safe Harbor Statement
neuralstem.com Safe Harbor Statement 3 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 1
Slide 4: The Company
neuralstem.com The Company Public Company: NASDAQ: CUR Market Capitalization: Approx. $6 MM Management: Being re - built under new Executive Chairman, Ken Carter, Ph.D. Business: Development of proprietary, first - in - class stem cell - based treatments for neurological diseases Stage of developmen
Slide 5: The Plan
neuralstem.com • Long Term – Re - build pipeline of clinical stage assets – Develop core team for therapeutic development and commercialization – Therapeutic focus: Neural diseases and complimentary indications • Near Term – Recapitalize company; – Implement new clinical development strategy to driv
Slide 6: Rebuilding Neuralstem
neuralstem.com • Established credible executive management team: – Deep expertise in therapeutic product development – Proven track records in biotechnology company operations • Streamline and partner development activities of existing pipeline – Focus on clinical milestones – Highest likelihood of
Slide 7: Management team and advisors
neuralstem.com Matt Kalnik* Consultant: Operations, R&D Tom Hazel VP of R&D David Recker* Chief Medical Officer Don Elsey* Consultant: Financial VP Regulatory VP Manufacturing Ken Carter Executive Chairman • 20+ years as CEO/Chairman of public and private companies • Multiple successful companies •
Slide 8: Streamlined Pipeline To Focus On Top Clinical Programs
neuralstem.com 8 Streamlined Pipeline To Focus On Top Clinical Programs - Existing And Newly Augmented 2019 2020 2021 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 566 Ph2 Stroke , non - GCP (China) 566 Pivotal Stroke (Ph2) 189 To be out - licensed Indication not disclosed Asset #2 (Clinical Phase I/II) Asset #3 (C
Slide 9: The Science
neuralstem.com 9 The Science Glial Progenitors Neuronal Progenitors Neural Stem Cell Neurons Astrocytes Oligodendrocytes Cell Therapy (NSI - 566) • ALS • Stroke • SCI Drug Screening • Neurogenesis • Neurotoxicity • Disease models NSI - 189 • Cognition • Diabetic Neuropathy • Alzheimer’s disease Self
Slide 10: Target indications: ALS, chronic stroke, spinal cord injury
neuralstem.com • Amyotrophic Lateral Sclerosis: Orphan drug opportunity provides fast path to market – 53K prevalent cases in the 7 major markets in 2017 (US, 5EU, Japan); annual incidence 5600 (US) – Few approved therapies with nominal effectiveness – Many heterogenous subtypes, but treatment appro
Slide 11: Newly Diagnosed ALS Population Is A $1B+ Opportunity
neuralstem.com • US ALS market opportunity – 5,600 ALS patients newly diagnosed in United States annually – Limited treatment options with poor efficacy – Median time from onset of symptoms to death is 3 years • US NSI - 566 addressable market – ~65% of newly diagnosed patients likely eligible for N
Slide 12: Clinical development programs by indication
neuralstem.com • ALS Phase I & II (n=3 1 ): demonstrate d preliminary clinical benefit against historical data. – Assess and plan pivotal study in the US, meet with FDA – Seek non - dilutive financing for conduct of clinical trial • cStroke Phase I & II (n= 20 ): demonstrate d safety and preliminary
Slide 13: ALS Phase I & II Ambulatory Subjects
neuralstem.com ALS - Phase I & II Ambulatory Subjects: NSI - 566 Indication of Efficacy When Compared To Historical Controls ALSFRS - R Total Score Time to Death or Motor Subscale ≤ 6 P=0.005 HSSC HSSC non - bulbar subjects 13 PhI /II NSI - 566
Slide 14: ALS Is An Attractive Orphan Opportunity
neuralstem.com ALS Is An Attractive Orphan Opportunity Where NSI - 566 Would Be a Differentiated Offering Defined regulatory path and opportunity to differentiate from other treatments by superior, disease - modifying efficacy 1 Substantial opportunity (53K patients US+EU+JP) accessible with modest
Slide 15: Chronic Ischemic Stroke: Significant Opportunity
neuralstem.com Chronic Ischemic Stroke: Significant Opportunity Commercially Attractive Indication With Few Competitors • Substantial population size: The most common cause of disability in the United States with an estimated survivor population of 7MM (US) and 17MM (Worldwide). Prevalent cases will
Slide 16: 2017 Ranking Of Death And Disability
neuralstem.com Death Pre - mature Death Disability Risk Factors 1 Stroke Stroke Neck Pain Dietary risks 2 Ischemic Heart Disease Ischemic Heart Disease Depressive Disorders Tobacco 3 COPD Lung Cancer Hearing Loss High Blood Pressure 4 Lung Cancer COPD Low back pain Air Pollution 5 Alzheimer's Liver
Slide 17: Chronic Stroke Treatment Is A Global Blockbuster Opportunity
neuralstem.com • Ischemic Chronic Stroke Market Opportunity – 692K newly diagnosed patients annually in the US – China is second largest stroke market opportunity – Therapies limited to rehabilitation; no regenerative approved therapies – 25% survival rate by 10 years • NSI - 566 Addressable Market
Slide 18: Chronic Stroke Phase I Data
neuralstem.com NSI - 566: Chronic Stroke – Phase I Data A t 12 Months Motor score improvement Fugl - Meyer Motor Score Post Treatment (months, 0 - 12) Meaningful Clinical Benefits: >10 points of improvement in Fugl - Meyer Motor Score Change from Baseline (+/ - SEM) • One - time administration of 72
Slide 19: Chronic Stroke Represents A Very Large Opportunity
neuralstem.com Chronic Stroke Represents A Very Large Opportunity Where NSI - 566 Has Potential To Partially Restore Motor Function Where No Interventional Therapy Currently Exists No restorative interventional therapies approved in chronic stroke (Breakthrough potential) 1 4 Substantial opportunity
Slide 20: NSI-189: A Small Molecule Pro-Cognitive Drug
neuralstem.com NSI - 189: A Small Molecule Pro - Cognitive Drug MOA: Neurogenesis, Synaptogenesis, Synaptic Plasticity • Pro - cognitive, neurogenic small molecule • Positive, randomized placebo - controlled Phase Ib in major depressive disorder (MDD) • Phase II double - blind exploratory study in M
Slide 21: New Asset Search, Evaluate And Acquire
neuralstem.com New Asset Search, Evaluate And Acquire • Re - build the pipeline and acquire new assets • Retained Hibiscus BioVentures – Focused on M&A/Corporate Development, technology sourcing and acquisition, licensing, financing support – Significant track record, distinguished team, and strong
Slide 22: Neuralstem New Asset Search Process
neuralstem.com STAGE 1 STAGE 2 STAGE 3 STAGE 4 STAGE 5 • “Triage” based on high level criteria (clinical space, commercial opportunity, “fit”, etc.) • 60 - 70 Technologies Evaluated • Data and technology vetted by group of technical/clinical analysts • Initial business and IP evaluation • 10 Reached
Slide 23: Summary
neuralstem.com Summary • Plan: Re - build pipeline of clinical stage assets • Team: New team with deep expertise and experience • Assets: Build on promise of current products, add additional assets • Partnering: Establish strong regional and global development partnerships • Financing: Raise initial
Slide 24: neuralstem.com
neuralstem.com