Nexien Biopharma, Inc. · OTC:NXEN
Nexien Biopharma — Investor Presentation (March 2019)
33 slides from Nexien Biopharma's investor presentation, Mar 8, 2019
Slide 1: The Future of Cannabinoid Biotechnology
The Future of Cannabinoid Biotechnology Investor Presentation March 2019 OTCQB: NXEN
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains “forward-looking statements” as that term is defined in the Private Securities Ligation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or an behalf of the Company that are not statements of hi
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 PATH ONE Developing, licensing and commercializing cannabinoid based medications for specific medical conditions and disorders. Our drug development activities are undertaken in accordance with Food and Drug Administration (FDA) or comparable development pathways in oth
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 gra
Slide 8: Drug Development Strategy
DRUG DEVELOPMENT STRATEGY NEXIEN’S R&D ARCHITECTURE * The determination of rnedical 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 pur
Slide 9: Nexien's Distinct Technology Advantages
NEXIEN’S DISTINCT TECHNOLOGY ADVANTAGES Fast Acting Parenteral Formulation Technology: The first non- hospital, r | ~non-psychoactive, and non-habit forming cannabinoid auto-injection rescue treatment for the Company’s target indications. ] . Sustained Release Parenteral Formulation Technology: A no
Slide 10: Summary of Drug Development Pipeline
SUMMARY OF DRUG DEVELOPMENT PIPELINE: &) FLAGSHIP PROGRAMS = Therapeutic Patent Formulation Areas Identifiers Identifiers @) Convulsive Disorders NXENOL NX01R1, NX02R2, NXO1L1, NX01L2, NX04S1, NX04S2 (®) Myotonic Dystrophy NXENO4 NXx04S1, NxX04S2 Organophosphate/Carbamate Toxicity NXENO8, 2019 TBD P
Slide 11: Convulsive Disorders: Epilepsy & Refractory Epilepsy
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY INDICATION OVERVIEW DEFINITIONS W 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, +
Slide 12: Convulsive Disorders: Market Overview
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY MARKET OVERVIEW 3.4 50 million | million People with epilepsy (US) People are affected by epilepsy worldwide 30-40% Of patients with epileptic seizures fail to respond to antiepileptic drugs In 2015, 1.2% of the US Population had active epilepsy (
Slide 13: Convulsive Disorders: Treatment Market
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY one, TREATMENT MARKET Ada COST OF TREATMENT Treatment costs specific to epilepsy per patient: $5.9 $2 s) Upto > $19,749/year billion By 2024 {all sub-groups): billion By 2024 Total costs per patient Upto > $47,862/year Begley, C. E and Durgin, T.
Slide 14: Benefit
+) Benefit Patient Quality of Life Pk/Pd Optimization Bioavailability Regulatory/Quality Control 14
Slide 15: Nexien's Distinct Opportunity
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY one, NEXIEN’S DISTINCT OPPORTUNITY 2 GWPH's research and : fg lid Current Nexien solves intrinsic standard of care approval of Epidiolex® yeeen poorly treats increases greenfield Pupaisiis a oral and our target + outlook for additional | + ora eBi
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 lvy League University Medical School Study Design: Two Parts * Part (1) — Maximum Tolerated Dose and PK/PD method development and sample analysis in m
Slide 17: Bioavailability Competitive Advantages
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY G 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 1. Hu
Slide 18: Myotonic Dystrophy: Indication Overview
MYOTONIC DYSTROPHY &) INDICATION OVERVIEW . DEFINITIONS W 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. T
Slide 19: Myotonic Dystrophy: 2019 Research Objectives
MYOTONIC DYSTROPHY 2019 RESEARCH OBJECTIVES @) Completion of Internal POC Investigation Primary Endpoint: ¢ Reduction of myotonia by 1 point on the Myotonic Behavior Scale (MBS) after 12 weeks Secondary Endpoint(s)- Including, but not limited to: ¢ The stiffness diary: all subjects shall fill in a 1
Slide 20: Myotonic Dystrophy: Market Overview
MYOTONIC DYSTROPHY ) MARKET OVERVIEW 29, 1 in 39.5 in 8,000 | 100,000 Affected worldwide Affected by DM1 alone in the United States U.S. Projected to Dominate DM Drug Market Romitti PA, Zhu Y, Puzhankara S, James KA, Nabukera SK, Zamba GK, Ciafaloni , Cunniff C, Druschel CM, Mathews KD, Matthews DJ,
Slide 21: Myotonic Dystrophy: Treatment Market
MYOTONIC DYSTROPHY > TREATMENT MARKET 2a COST OF TREATMENT $4. 1 Total costs per patient (US), (DM, types 1 and 2): $32,236/year Population-wide national costs (US): $448 million/year Larkindale, J. , Yang, W. , Hogan, P. F., Simon, C. J,, Zhang, ¥. , Jain, A, Habbeetp-Louks, E. M., Kennedy, A. and
Slide 22: 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) Muscul
Slide 23: Summary of Milestones for Flagship Programs
SUMMARY OF MILESTONES FOR FLAGSHIP PROGRAMS CATALYSTS ON THE HORIZON NXENO1: Convulsive Disorders «a io Begin MTD, PK/PD study at Iv Pre-IND meeting with FDA League University Medical School 2019 IND Application with FDA Finalize pre-study formulation stability testing NXENO4: Myotonic Dystrophy 201
Slide 24: Early Sub-Licensing Revenue Opportunities
EARLY SUB-LICENSING REVENUE OPPORTUNITIES EXCLUSIVE ACCU-BREAK LICENSE Exclusive License . . . Top Layer contains drug ¢ Nexien has an exclusive license from Accu-Break & \, j formulation for the use of Accu-Break technology including at least one cannabinoid, for use in humans and ee t animals. She
Slide 25: Management and Scientific Advisory Board
Alex Wasyl, Chief Executive Officer CEO/Co-Founder, CRx Bio Holdings Managing Director, Elevated Life Sciences BS, The College of New Jersey Frank J. Manganella, VP - Corporate Development Interim CFO/Managing Partner, CRx Bio Holdings Co Global Head of FICC, Handelsbanken Capital Markets Head of Em
Slide 26: Appendix
APPENDIX
Slide 27: Peer Landscape
PEER LANDSCAPE CANNABINOID PHARMACEUTICAL COMPANIES COMPANY DESCRIPTION DOSING APPROVED MARKET CAP + Marinol® synthetic THC compound for chemmotherapy-induced nausea and Oral 1985 (US) 116,974 AOOVIE somiting ciny capsules Epidiolex® natural, plant-based purified form of CBD for treatment of rare, O
Slide 28: Intellectual Property Summary
INTELLECTUAL PROPERTY SUMMARY: FLAGSHIP PROGRAMS Intellectual Property Position: Patent claims focus on the protection of therapeutic methods for the use of cannabinoid-based pharmaceuticals, their composition of matter, and medical delivery devices where applicable IP protection in multiple countri
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
Slide 30: Nexien vs. Current Standard of Care
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY NEXIEN VS. CURRENT STANDARD OF CARE Current Standard of Care: (Benzodiazepines) sna —_—— at =— Ss Boe ' fa 7. PROS: ee i " : a as! ‘~ —¥ ¢ Currently available to help manage generalized and refractory — ea SS epilepsy patients CONS: LEFT: Diazepam
Slide 31: New Treatment Opportunities
CONVULSIVE DISORDERS: EPILEPSY & REFRACTORY EPILEPSY G NEW TREATMENT OPPORTUNITIES td New Treatment Opportunity: (Cannabinoids) > NXO1R1, NXO1R2 NXO1L1, NXO1L2 ADVANTAGES TOP: Rapid release cannabinoid matrix ¢ Nexien's L Series Formulations: Sustained release, non- solution (Rescue Administration)
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 FIGURE 1. GWPD9901: Mean Plasma Cannabinoid Concentrations Following TABLE 6. Mean Pharmacokinet
Slide 33: Contacts
CONTACTS NeXleN EG EQUITY GROUP BIOPHARMA INC ese TRUSTED PARTNERS IN TR SINCE 1974 G Alex Wasyl, CEO Kalle Ahl, CFA awasyl@ nexienbiopharma.com (212) 836-9614 kahI@ equityny.com Devin Sullivan (212) 836-9608 dsullivan@equityny.com
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