Nexien Biopharma, Inc. · OTC:NXEN
Nexien Biopharma — Investor Presentation (March 2019)
33 slides from Nexien Biopharma's investor presentation, March 2019
Slide 1: The Future of Cannabinoid Biotechnology
The Future of Cannabinoid Biotechnology Investor Presentation March 2019 OTCQB: NXEN ©2019 NEXIEN BIOPHARMA INC. All rights reserved.
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of
Slide 3: Mission and Vision
MISSION AND VISION MISSION To develop and commercialize the next generation cannabinoid pharmaceuticals, drug delivery systems, and related technologies. VISION In accordance with domestic and international federal regulatory and approval pathways, Nexien is pioneering initial investigation of novel
Slide 4: Who Is Nexien Biopharma?
WHO IS NEXIEN BIOPHARMA? • We are a next generation biopharmaceutical company focused on research, development and commercialization of novel FDA-compliant cannabinoid pharmaceuticals and related drug delivery systems. • We are utilizing cannabinoids as the Active Pharmaceutical Ingredients (APIs) t
Slide 5: Three-Pronged Growth Strategy
THREE-PRONGED GROWTH STRATEGY Developing, licensing and The development and licensing of Investments in companies, and the commercializing cannabinoid based proprietary delivery systems for acquisition of technologies, or medications for specific medical cannabinoid medications. In addition medicati
Slide 6: Investment Highlights
INVESTMENT HIGHLIGHTS Significant Greenfield Opportunity in the Cannabinoid Pharmaceutical Space Experienced Management Team with Proven Industry Track Record Advancing Novel Drug Formulations with Differentiated Therapeutic Benefits (Compared to Existing FDA-Approved Cannabinoid Pharmaceuticals) Fl
Slide 7: A Significant Opportunity in Greenfield Pharmaceutical Class: Cannabinoids
A SIGNIFICANT OPPORTUNITY IN GREENFIELD PHARMACEUTICAL CLASS: CANNABINOIDS Cannabinoid pharmaceuticals will be as large as recreational and medicinal market within 15 years Medical Marijuana: Rx Cannabinoid • Federally illegal (DEA Sch. 1) Pharmaceuticals: • State medical markets • Federally legal g
Slide 8: Nexien's R&D Architecture
DRUG DEVELOPMENT STRATEGY NEXIEN’S R&D ARCHITECTURE • The determination of medical conditions and disorders that could prospectively benefit from cannabinoid-based formulations • Conducting 'freedom to operate' investigations on these conditions • The preparation of patent applications and the pursu
Slide 9: Nexien's Distinct Technology Advantages
NEXIEN’S DISTINCT TECHNOLOGY ADVANTAGES Fast Acting Parenteral Formulation Technology: The first non-hospital, non-psychoactive, and non-habit forming cannabinoid auto-injection rescue treatment for the Company’s target indications. Sustained Release Parenteral Formulation Technology: A non-psychoac
Slide 10: Summary of Drug Development Pipeline: Flagship Programs
SUMMARY OF DRUG DEVELOPMENT PIPELINE: FLAGSHIP PROGRAMS Therapeutic Patent Formulation Areas Identifiers Identifiers Convulsive Disorders NXEN01 NX01R1, NX02R2, NX01L1, NX01L2, NX04S1, NX04S2 Myotonic Dystrophy NXEN04 NX04S1, NX04S2 Organophosphate/Carbamate Toxicity NXEN08 2019 TBD Pain Disorders N
Slide 11: Convulsive Disorders: Epilepsy & Refractory Epilepsy Indication Overview
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY INDICATION OVERVIEW DEFINITIONS Epilepsy & Refractory Epilepsy Epilepsy Neuropathology Often associated with: Epilepsy: A neurological disorder marked by sudden recurrent episodes of sensory disturbance, loss of consciousness, or convulsions, • Bi
Slide 12: Epilepsy & Refractory Epilepsy Market Overview
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY MARKET OVERVIEW 3.4 50 30-40% million million Of patients with epileptic seizures fail to respond to People with epilepsy (US) People are affected by antiepileptic drugs In 2015, 1.2% of the US Population had epilepsy worldwide active epilepsy (95
Slide 13: Epilepsy & Refractory Epilepsy Treatment Market
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY TREATMENT MARKET COST OF TREATMENT Treatment costs specific to $5.9 $2.5 epilepsy per patient: Up to → $19,749/year billion billion By 2024 Total costs per patient (all sub-groups): By 2024 Up to → $47,862/year Begley, C. E. and Durgin, T. L. (201
Slide 14: Problem and Nexien's Solution
Nexien’s Problem Solution Benefit Refractory epilepsy is poorly treated by Lack of FDA-approved treatment options for refractory epilepsy with rapid existing stand of care. Existing standard of Patient Quality of Life care promotes unwanted side effects and intervention capability. physiological add
Slide 15: Nexien's Distinct Opportunity
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY NEXIEN’S DISTINCT OPPORTUNITY Current GWPH’s research and approval of Epidiolex® Nexien solves intrinsic standard of care limitations of oral and poorly treats increases greenfield our target + outlook for additional + oral-mucosal cannabinoid del
Slide 16: Nexien's 2019 Pre-Clinical Research Objectives
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY NEXIEN’S 2019 PRE-CLINICAL RESEARCH OBJECTIVES Sponsored Research Collaboration with a Leading Ivy League University Medical School Study Design: Two Parts • Part (1) – Maximum Tolerated Dose and PK/PD method development and sample analysis in mic
Slide 17: Bioavailability Competitive Advantages
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY BIOAVAILABILITY COMPETITIVE ADVANTAGES Parenteral vs. Non-Parenteral Bio-Availability Comparison Intravenous (as a model for injected parenteral RoA) bio-availability of cannabinoids vastly outweighs that of other routes of administration Cannabin
Slide 18: Myotonic Dystrophy Indication Overview
MYOTONIC DYSTROPHY INDICATION OVERVIEW DEFINITIONS MYOTONIC DYSTROPHY (DM) TYPE 1 – TYPE 2 Myotonic Dystrophy: Myotonic dystrophy is part of a group Signs and symptoms overlap, although type 2 of inherited disorders called muscular dystrophies. It is the most tends to be milder than type 1. The musc
Slide 19: Myotonic Dystrophy 2019 Research Objectives
MYOTONIC DYSTROPHY 2019 RESEARCH OBJECTIVES Completion of Internal POC Investigation Phase I Human Trials Primary Endpoint: 2019 Objectives: • Reduction of myotonia by 1 point on the Myotonic • To complete pre-IND meeting with FDA Behavior Scale (MBS) after 12 weeks • Prepare for IND application wit
Slide 20: Myotonic Dystrophy Market Overview
MYOTONIC DYSTROPHY MARKET OVERVIEW 1 in 39.5 in U.S. Projected to Dominate 8,000 100,000 DM Drug Affected worldwide Affected by DM1 alone in the United States Market Romitti PA, Zhu Y, Puzhankara S, James KA, Nabukera SK, Zamba GK, Ciafaloni E, Cunniff C, Druschel CM, Mathews KD, Matthews DJ, Meaney
Slide 21: Myotonic Dystrophy Treatment Market
MYOTONIC DYSTROPHY TREATMENT MARKET COST OF TREATMENT $4.1 Total costs per patient (US), (DM, types 1 and 2): $32,236/year billion Population-wide national costs (US): By 2024 $448 million/year Larkindale, J. , Yang, W. , Hogan, P. F., Simon, C. J., Zhang, Y. , Jain, A. , Habeeb‐Louks, E. M., Kenned
Slide 22: Myotonic Dystrophy Internal Proof of Concept Investigation
MYOTONIC DYSTROPHY INTERNAL PROOF OF CONCEPT INVESTIGATION Nexien’s Internal Proof of Concept Patient Investigation with World Renowned Myotonic Dystrophy Physician. Design – Four (4) week, open-label individual treatment assessment in myotonic dystrophy using clinical surrogate markers a) Muscular
Slide 23: Summary of Milestones for Flagship Programs
SUMMARY OF MILESTONES FOR FLAGSHIP PROGRAMS CATALYSTS ON THE HORIZON NXEN01: Convulsive Disorders Begin transgenic mouse efficacy study at Ivy League University Medical School 2019 2020 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Begin MTD, PK/PD study at Ivy Pre-IND meeting with FDA League University Medical Sch
Slide 24: Early Sub-Licensing Revenue Opportunities: Exclusive Accu-Break License
EARLY SUB-LICENSING REVENUE OPPORTUNITIES EXCLUSIVE ACCU-BREAK LICENSE Exclusive License Top Layer contains drug • Nexien has an exclusive license from Accu-Break formulation for the use of Accu-Break technology including at least one cannabinoid, for use in humans and animals. Nexien's Advantage Bo
Slide 25: Management Team and Scientific Advisory Board
MANAGEMENT TEAM AND SCIENTIFIC ADVISORY BOARD Alex Wasyl, Chief Executive Officer Joseph Aceto, JD, PhD, VP – Legal/IP Counsel; Director, Translational Research • CEO/Co-Founder, CRx Bio Holdings • Counsel, Obermayer Rebmann Maxwelll and Hippel LLP • Managing Director, Elevated Life Sciences • Gener
Slide 26: Appendix
APPENDIX 26
Slide 27: Peer Landscape: Cannabinoid Pharmaceutical Companies
PEER LANDSCAPE CANNABINOID PHARMACEUTICAL COMPANIES (2/28/19, $mm) COMPANY DESCRIPTION DOSING APPROVED MARKET CAP Marinol® synthetic THC compound for chemotherapy-induced nausea and Oral 1985 (US) 116,974 vomiting (CINV) capsules Epidiolex® natural, plant-based purified form of CBD for treatment of
Slide 28: Intellectual Property Summary: Flagship Programs
INTELLECTUAL PROPERTY SUMMARY: FLAGSHIP PROGRAMS Intellectual Property Position: NXEN01 (PCT/US18/59871) - Convulsive Disorders, International Phase pending Patent claims focus on the protection of therapeutic methods for the use of cannabinoid-based NXEN02 (US62617193) - Chronic Traumatic pharmaceu
Slide 29: Parenteral RoA of Cannabinoids
PARENTERAL ROA OF CANNABINOIDS Core Differentiation from Oral Administration: Parenteral Administration Advantages Bio-availability: ✓ Oral formulations suffer from poor bio-availability (avg. ~<10%), first pass metabolism variability, and less controllable Pk/Pd Favorable Economics: ✓ No wasted API
Slide 30: Nexien vs. Current Standard of Care
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY NEXIEN VS. CURRENT STANDARD OF CARE Current Standard of Care: (Benzodiazepines) PROS: • Currently available to help manage generalized and refractory epilepsy patients CONS: LEFT: Diazepam Oral (Chronic Administration) MIDDLE: Diastat® (Rectal Adm
Slide 31: New Treatment Opportunities
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY NEW TREATMENT OPPORTUNITIES New Treatment Opportunity: (Cannabinoids) NX01R1, NX01R2 NX01L1, NX01L2 ADVANTAGES TOP: Rapid release cannabinoid matrix • Nexien's L Series Formulations: Sustained release, non- solution (Rescue Administration) BOTTOM:
Slide 32: PK/PD Competitive Advantages
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY PK/PD COMPETITIVE ADVANTAGES Non-Parenteral Formulation References Problem: Slow onset (peak plasma concentrations) and low relative bio-availability NX01R1, NX02R2 Intramuscular (grey) or Intravenous (yellow) GW Pharma – oral-mucosal peak CBD pla
Slide 33: Contacts
CONTACTS Alex Wasyl, CEO Kalle Ahl, CFA awasyl@nexienbiopharma.com (212) 836-9614 kahl@equityny.com Devin Sullivan (212) 836-9608 dsullivan@equityny.com
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