Jonathan Pirkl, VP of Business Development

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Presentation transcript:

Jonathan Pirkl, VP of Business Development A Clinical Stage Drug Company Developing Polymolecular Therapeutics For The Oncology, Neurology And Orthopedic Markets Jonathan Pirkl, VP of Business Development jonathanp@unitedcannabis.us 813-438-9998

COMBINATORIAL TARGETING THE PROBLEM OUR SOLUTION Most diseases have multifactorial causes and hence are driven by multiple factors. This helps to explain marginal outcomes and the high rate of failure in new drug development.. Involves identification of novel combinatory targets based on preclinical and clinical efficacy data using our Polymolecular Botanical Drug platform COMBINATORIAL TARGETING At the core of our platform is the conviction that unlike many pharmaceuticals, botanical compounds are heterogeneous with multiple active components that are able to modulate multiple mechanisms through COMBINATORIAL TAGETING to combat disease progression.

Timeline Patents filed in USA & internationally (composition of matter and use claims) Technology developed at University of Florida Preclinical phase completed Clinical studies begin 2018 Incorporated in Delaware in November 2012 Exclusive, world-wide license to the technology acquired by Prana Therapeutics, Inc. in 2017 Over 600K raised: grant & research contract, founders

Epidiferphane™ 1 2 3 Proprietary blend of 3 botanical compounds developed & owned by Prana Therapeutics 1 2 3 Catechin from green tea Curcumin [potent anti-inflammatory] Sulforaphane [nature’s most potent anti-oxidant regulator] Supplement Epidiferphane™ Marketing Opportunities Drug

R & D PROGRAM DRUG DEVELOPMENT PROGRAM 2018 2019 2020 2021 2022 Phase I/II Phase III Preventing Chemotherapy Side-effects Phase I/II Phase III Inflammatory Disease Back Pain & Arthritis Phase I Phase II Cancer High Grade Glioma Phase III Pre-clinical Testing Clinical Testing

Current Market Size Preventing Chemotherapy Side-effects Annual Sales Notes # Patients per year Preventing Chemotherapy Side-effects 650K $12B Largely an unmet need, with no therapies to prevent Inflammatory Disease Back Pain Arthritis 91M $17B Plethora of treatments, many have significant side effects 46M $15B Cancer High Grade Glioma Our approach is meant as an adjunctive treatment used together with standard of care 23K $0.4B

Product Development Workflow DISCOVERY: Tissue Culture & Animal Models are used to Identify Poly molecular Therapeutics First Products are Engineered for the Supplement Market STAGE 01 Based on preclinical and limited clinical data PMBS [PolyMolecular Botanical Supplement] PMBS Undergo Rigorous FDA Clinical Trial Evaluation Intended for New Drug Approval [NDA] STAGE 02 PMBD [Poly Molecular Botanical Drug] FDA Approved PMBD will be Developed into Synthetic Drugs Based on Successful STAGE 03 PMSD [PolyMolecular Synthetic Drug]

Attenuating the side effects of Chemotherapy NO THERAPIES EXIST to prevent these side effects which are often treatment limited, diminish treatment efficacy & reduce quality of life. Each year in the USA there are approximately: Over 90% of chemotherapy pts. experience at least one of the following negative side-effects: 1.6M New Cancer Diagnosis Anemia Low red blood cells Chemotherapy Induced Peripheral Neuropathy 650K New Chemotherapy Pits Neutropenia Low white blood cells Memory Problems Chemo fog or Chemo brain

Attenuating the side effects of Chemotherapy Anemia Neutropenia Epidiferphane™ when given with chemotherapy prevents 4 major negative side effects of chemotherapy Neuropathy Neural stem cells

Inflammatory Disease Back pain and arthritis 75% of responders saw improvement with an average improvement of 50% 75% of responders saw improvement with an average improvement of 45% 100% of responders saw improvement with an average improvement of 60% How often were you in a bed or chair most or all of the day? Did you have trouble doing vigorous exercise? How often do you have severe pain from your arthritis?

Inflammatory Disease Back pain and arthritis 75% of responders saw improvement with an average improvement of 50% 75% of responders saw improvement with an average improvement of 60% 75% of responders saw improvement with an average improvement of 50% How often does morning stiffness last for more than 1 hour? How often does the pain make it difficult to sleep? How often have you felt tense or high strung?

NO EFFECTIVE THERAPIES EXIST to treat Stage IV gliomas or Glioblastoma Cancer High Grade Glioma Epidiferphane™ when combined with a low carb [LC] diet has been demonstrated to: Increase survival of human tumors in a rodent Work synergistically with chemotherapy Sensitize chemotherapy resistant tumors to standard of care drugs NO EFFECTIVE THERAPIES EXIST to treat Stage IV gliomas or Glioblastoma Each year in the USA there are approx. 80K new brain cancer diagnoses The most common type, Glioblastoma, has a survival diagnosis of approximately 12 months. Epidiferphane™ when combined with a low carb diet doubles mean life expectancy

OUR PARTNERS CLINICAL TRIAL SITES

FOUNDERS MANAGEMENT BOARD OF DIRECTORS Brent Reynolds, Ph.D. Brent Reynolds, Ph.D. Brent Reynolds, Ph.D. Prof Neurosurgery, University of Florida President Founder & President Prana Therapeutics Dennis Steindler, Ph.D. Courtney Simmons, M.Ed. Earnie Blackmon SVP of Program Management CEO United Cannabis Director Neuroscience and Aging Lab, Tufts University John Walsh Ben Griffith, B.Sc. CFO United Cannabis Loic Deleyrolle, Ph.D. Project Manager Res Asst Prof, University of Florida