A Clinical Stage Drug Company Developing Polymolecular Therapeutics For The Oncology, Neurology And Orthopedic Markets Dr. Brent Reynolds, CEO brent@pranatherapeutics.com.

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Presentation transcript:

A Clinical Stage Drug Company Developing Polymolecular Therapeutics For The Oncology, Neurology And Orthopedic Markets Dr. Brent Reynolds, CEO brent@pranatherapeutics.com 415-754-9591

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 Technology developed at University of Florida Patents filed in USA & internationally [composition of matter and use claims] Over 600K raised: grant & research contract, founders Preclinical phase completed Incorporated in Delaware in November 2012 Exclusive, world-wide license to the technology acquired by Prana Therapeutics, Inc. in 2017 Clinical studies begin 2017 Current opportunity: $4M (phase I/II clinical trials)

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 2017 2018 2019 2020 2021 Phase I/II Phase III Preventing Chemotherapy Side-effects Phase I/II Phase III Inflammatory Disease Back Pain & Arthritis Phase II Cancer High Grade Glioma Phase I Phase III Pre-clinical Testing IND – Investigation New Drug NDA – New Drug Application 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 ADVISORY BOARD Brent Reynolds, Ph.D. Don McKinney, MBA Angelo Vescovi, Ph.D. Prof Neurosurgery, University of Florida Chairman of the Board Dennis Steindler, Ph.D. Brent Reynolds, Ph.D. Santosh Kesari, MD, Ph.D. Chair Dept. Translation Neurosciences, Pacific Neuroscience Institute Director Neuroscience and Aging Lab, Tufts University President Loic Deleyrolle, Ph.D. Res Asst Prof, University of Florida

Phase I/II Clinical Trial 50 % OPPORTUNITY 03 1st Round Data Analysis Manufacturing Biomarker Analysis Clinical Support Patent support Biomarker 30% R & D 20% SG&A + Patents Phase I/II Clinical Trial 50 % Management $4M Offering Patent Costs