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Corporate presentation 2013 cytorex biosciences inc

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Carlos Manuel Garcia-Arcaya, MEIE
Carlos Manuel Garcia-Arcaya, MEIE

Maria Lopez maria@cytorex.com Tel: 954-573-4006

1 of 14
Cytorex Biosciences, Inc. Corporate Presentation 2013
Introduction This presentation describes Cytorex Bioscience, Inc.; a Florida based preclinical stage Biopharmaceutical Company developing new therapies based on its expertise in pharmacologically active low pH acidic formulations. Cytoreg速, the Companys lead drug candidate, is currently in preclinical development for various cancers.
Market Overview In 2007, worldwide sales of cancer therapies totaled USD $42.2 billion. Within the 7 major markets (US, Japan, France, Germany, Italy, Spain, and the United Kingdom), sales amounted to USD $34.3 billion. These sales are expected to grow at a compound annual growth rate (CAGR) of 12% between 2006 and 2013, almost 3 times faster than the pharmaceutical industry as a whole, reaching USD $55 billion by 2012.
Focus Cytorex intends to initially focus development efforts of Cytoreg速 on cancer types with high levels of unmet need: Glioblastoma Multiforme (grade IV brain tumor); pancreatic cancer; and metastatic melanoma. Cytoreg速 may also be developed for brain metastases. These four cancer types have low survival rates, are currently underserved with existing marketed therapies and have few pipeline products.
Technology Overview Cytorex has developed a number of therapeutic candidates based on its US patented pharmacologically active low pH acidic technology for a wide range of disorders, including cancer and diseases of immunological origin. Cytoreg速 is Cytorex lead drug candidate and is the primary focus of this presentation. Cytoreg速, a novel cancer therapeutic candidate, is a formulation of balanced acids, where hydrofluoric acid (HF) is the key active ingredient. Cytoreg速 may be used to treat several types of cancers, including solid tumors and hematological malignancies.
Portfolio PRODUCT STAGE APPLICATION 1 Cytoreg: Development Currently in preclinical development stage for these indications: 1) Brain Tumors (Glioblastoma Multiforme); 2) Pancreatic Cancer and 3) Metastatic Melanoma (skin cancer). Also being investigated in brain metastases. 2 CytoregUNO Development skin cancer such as basal cell cancer, squamous cell cancer, sarcoma, melanoma, and disorders caused by fungi, viruses and bacteria on the skin. 3 CytoCardio Discovery Product for treatment of hypertension 4 CytoKStones : Discovery Product for treatment of Kidney Stones 5 CytoNeuroSys Discovery Product for treatment of MS, Alzheimers, Parkinsons, and chronic diseases like epilepsy. 6 CytoOS Discovery Product for treatment of Otosclerosis 7 CytoDiabet Discovery Product for treatment/regulation of Diabetes 8 CytoAntioxidant Discovery Antioxidant 9 CytoHormone Discovery Product for treatment of hormonal disorders
Selectivity and MOA Preclinical studies in Glioblastoma Multiforme and other cancer cell types have demonstrated that Cytoreg速 has high specificity and selectivity in targeting and inhibiting cancer growth, as well as inducing selective apoptosis. Mechanisms of action studies have also been performed to understand how Cytoreg速 kills cancer cells. These studies have demonstrated that Cytoreg速: disrupts the cell membrane in brain cancer cell lines; acts independently of the tumor suppressor gene p53 and caspase cascade pathways; inhibits cancer cell growth factor; and induces selective apoptosis.
Key product advantages A targeted therapy with multiple mechanisms of action. Demonstrated potential to reduce tumor mass and/or stops tumor growth or even destroys the tumor. Favorable side effect profile, as demonstrated in human compassionate use program and in preclinical studies performed to date. Very low manufacturing costs.
Clinical Development Plan & Regulatory Strategy The Company expects that Cytoreg速 will be brought to market at a much faster pace than typical oncology products by targeting indications with high levels of unmet need, including Glioblastoma Multiforme; pancreatic cancer; and metastatic melanoma. By focusing on these indications, Cytoreg速 will be a candidate for Fast Track and Orphan Drug designations, and potentially accelerated approval by US Food & Drug Administration (USFDA). Our initial plan is to perform some preliminary clinical trials in Latin America, get approval for at least two indications, and then start the FDA/EMA approval process. If Funding is sufficient we may choose to initiate Clinical Trials directly in the USA.
Intellectual Property Cytorex believes the Companys intellectual property (IP) position is secure. The Company has one issued patent (US patent 7,141,251, Pharmacologically Active Strong Acid Solutions) containing over 70 claims related to composition and therapeutic use. Cytorex has developed a detailed patent prosecution strategy to further enhance its IP position in the US and worldwide. Cytorex IP estate has been reviewed by Mr. Michael Keller, Esq. Mr. Keller has over 20 years experience prosecuting biomedical drug, diagnostic and device patents.
Management Team Prof. David Martucci, Chairman, President, Chief Executive Officer and Chief Scientific Officer Mr. William Jimenez, Director, Vice-President, Treasurer and Chief Financial Officer Mr. Carlos M. Garcia, Director, Secretary & Chief Operations Officer Mr. Ramon Alvarez, Business Development Director
Key Advisors Dr. Kris Dhandapani, Scientific Consultant Mr. Michael J. Keller, Intellectual Property Attorney
Scientific Committee Dr. Kris Dhandapani, PhD, Assistant Professor, Neurology Department, Institute of Molecular Medicine and Genetics, Medical College of Georgia. Research Interest: Brain Cancer Tumors & Brain Injuries. Dr. James Kumi-Diaka, DVM, PhD, Prof. of Cancer Biology (Florida Atlantic University, Davie FL). Research Interest: Molecular Biology & Apoptosis. Dr. Manzur Hassanhi, MD, Professor of Immunology (University of Zulia, Venezuela). Research Interest: Clinical Oncology. Dr. Nelson Vicu単a, MD, Professor of Toxicology (University of los Andes, Merida, Venezuela), Research Interest: Toxicology & Pharmacology Dr. Paula Durante, PhD, Biological Research (Private Consulting) Research Interest: Physiology and Cellular Biochemical Mechanisms Dr. Rosa de Jes炭s, PhD (University of Los Andes, Merida, Venezuela) Research Interest: Animal Models
Cytorex Biosciences, Inc. Carlos M. Garcia, Managing Director & COO 4474 Weston Road No. 108 Weston, FL 33331 Direct: 954-573-4006 cmgarcia@cytorex.com Contact Information:

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Corporate presentation 2013 cytorex biosciences inc

  • 2. Introduction This presentation describes Cytorex Bioscience, Inc.; a Florida based preclinical stage Biopharmaceutical Company developing new therapies based on its expertise in pharmacologically active low pH acidic formulations. Cytoreg速, the Companys lead drug candidate, is currently in preclinical development for various cancers.
  • 3. Market Overview In 2007, worldwide sales of cancer therapies totaled USD $42.2 billion. Within the 7 major markets (US, Japan, France, Germany, Italy, Spain, and the United Kingdom), sales amounted to USD $34.3 billion. These sales are expected to grow at a compound annual growth rate (CAGR) of 12% between 2006 and 2013, almost 3 times faster than the pharmaceutical industry as a whole, reaching USD $55 billion by 2012.
  • 4. Focus Cytorex intends to initially focus development efforts of Cytoreg速 on cancer types with high levels of unmet need: Glioblastoma Multiforme (grade IV brain tumor); pancreatic cancer; and metastatic melanoma. Cytoreg速 may also be developed for brain metastases. These four cancer types have low survival rates, are currently underserved with existing marketed therapies and have few pipeline products.
  • 5. Technology Overview Cytorex has developed a number of therapeutic candidates based on its US patented pharmacologically active low pH acidic technology for a wide range of disorders, including cancer and diseases of immunological origin. Cytoreg速 is Cytorex lead drug candidate and is the primary focus of this presentation. Cytoreg速, a novel cancer therapeutic candidate, is a formulation of balanced acids, where hydrofluoric acid (HF) is the key active ingredient. Cytoreg速 may be used to treat several types of cancers, including solid tumors and hematological malignancies.
  • 6. Portfolio PRODUCT STAGE APPLICATION 1 Cytoreg: Development Currently in preclinical development stage for these indications: 1) Brain Tumors (Glioblastoma Multiforme); 2) Pancreatic Cancer and 3) Metastatic Melanoma (skin cancer). Also being investigated in brain metastases. 2 CytoregUNO Development skin cancer such as basal cell cancer, squamous cell cancer, sarcoma, melanoma, and disorders caused by fungi, viruses and bacteria on the skin. 3 CytoCardio Discovery Product for treatment of hypertension 4 CytoKStones : Discovery Product for treatment of Kidney Stones 5 CytoNeuroSys Discovery Product for treatment of MS, Alzheimers, Parkinsons, and chronic diseases like epilepsy. 6 CytoOS Discovery Product for treatment of Otosclerosis 7 CytoDiabet Discovery Product for treatment/regulation of Diabetes 8 CytoAntioxidant Discovery Antioxidant 9 CytoHormone Discovery Product for treatment of hormonal disorders
  • 7. Selectivity and MOA Preclinical studies in Glioblastoma Multiforme and other cancer cell types have demonstrated that Cytoreg速 has high specificity and selectivity in targeting and inhibiting cancer growth, as well as inducing selective apoptosis. Mechanisms of action studies have also been performed to understand how Cytoreg速 kills cancer cells. These studies have demonstrated that Cytoreg速: disrupts the cell membrane in brain cancer cell lines; acts independently of the tumor suppressor gene p53 and caspase cascade pathways; inhibits cancer cell growth factor; and induces selective apoptosis.
  • 8. Key product advantages A targeted therapy with multiple mechanisms of action. Demonstrated potential to reduce tumor mass and/or stops tumor growth or even destroys the tumor. Favorable side effect profile, as demonstrated in human compassionate use program and in preclinical studies performed to date. Very low manufacturing costs.
  • 9. Clinical Development Plan & Regulatory Strategy The Company expects that Cytoreg速 will be brought to market at a much faster pace than typical oncology products by targeting indications with high levels of unmet need, including Glioblastoma Multiforme; pancreatic cancer; and metastatic melanoma. By focusing on these indications, Cytoreg速 will be a candidate for Fast Track and Orphan Drug designations, and potentially accelerated approval by US Food & Drug Administration (USFDA). Our initial plan is to perform some preliminary clinical trials in Latin America, get approval for at least two indications, and then start the FDA/EMA approval process. If Funding is sufficient we may choose to initiate Clinical Trials directly in the USA.
  • 10. Intellectual Property Cytorex believes the Companys intellectual property (IP) position is secure. The Company has one issued patent (US patent 7,141,251, Pharmacologically Active Strong Acid Solutions) containing over 70 claims related to composition and therapeutic use. Cytorex has developed a detailed patent prosecution strategy to further enhance its IP position in the US and worldwide. Cytorex IP estate has been reviewed by Mr. Michael Keller, Esq. Mr. Keller has over 20 years experience prosecuting biomedical drug, diagnostic and device patents.
  • 11. Management Team Prof. David Martucci, Chairman, President, Chief Executive Officer and Chief Scientific Officer Mr. William Jimenez, Director, Vice-President, Treasurer and Chief Financial Officer Mr. Carlos M. Garcia, Director, Secretary & Chief Operations Officer Mr. Ramon Alvarez, Business Development Director
  • 12. Key Advisors Dr. Kris Dhandapani, Scientific Consultant Mr. Michael J. Keller, Intellectual Property Attorney
  • 13. Scientific Committee Dr. Kris Dhandapani, PhD, Assistant Professor, Neurology Department, Institute of Molecular Medicine and Genetics, Medical College of Georgia. Research Interest: Brain Cancer Tumors & Brain Injuries. Dr. James Kumi-Diaka, DVM, PhD, Prof. of Cancer Biology (Florida Atlantic University, Davie FL). Research Interest: Molecular Biology & Apoptosis. Dr. Manzur Hassanhi, MD, Professor of Immunology (University of Zulia, Venezuela). Research Interest: Clinical Oncology. Dr. Nelson Vicu単a, MD, Professor of Toxicology (University of los Andes, Merida, Venezuela), Research Interest: Toxicology & Pharmacology Dr. Paula Durante, PhD, Biological Research (Private Consulting) Research Interest: Physiology and Cellular Biochemical Mechanisms Dr. Rosa de Jes炭s, PhD (University of Los Andes, Merida, Venezuela) Research Interest: Animal Models
  • 14. Cytorex Biosciences, Inc. Carlos M. Garcia, Managing Director & COO 4474 Weston Road No. 108 Weston, FL 33331 Direct: 954-573-4006 cmgarcia@cytorex.com Contact Information: