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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.
CytoregĀ®, the Companyā€™s lead drug
candidate, is currently in preclinical
development for various cancers.
Market Overview
ā€¢ In 2007, worldwide sales of cancer therapies
totaled USD $42.2 billion.
ā€¢ Within the 7 major markets (US, Japan, France,
Germany, Italy, Spain, and the United Kingdom),
sales amounted to USD $34.3 billion.
ā€¢ 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
ā€¢ Cytorex intends to initially focus development
efforts of CytoregĀ® on cancer types with high
levels of unmet need: Glioblastoma Multiforme
(grade IV brain tumor); pancreatic cancer; and
metastatic melanoma.
ā€¢ CytoregĀ® 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
ā€¢ 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.
ā€¢ CytoregĀ® is Cytorex lead drug candidate and is the
primary focus of this presentation.
ā€¢ CytoregĀ®, a novel cancer therapeutic candidate, is a
formulation of balanced acids, where hydrofluoric
acid (HF) is the key active ingredient.
ā€¢ CytoregĀ® may be used to treat several types of
cancers, including solid tumors and hematological
malignancies.
Portfolio
PRODUCT STAGE APPLICATION
1
Cytoregā„¢: 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
CytoregUNOā„¢ 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
CytoCardioā„¢ Discovery Product for treatment of hypertension
4
CytoKStones ā„¢: Discovery Product for treatment of Kidney Stones
5
CytoNeuroSysā„¢ Discovery Product for treatment of MS, Alzheimerā€™s,
Parkinsonā€™s, and chronic diseases like
epilepsy.
6
CytoOSā„¢ Discovery Product for treatment of Otosclerosis
7
CytoDiabetā„¢ Discovery Product for treatment/regulation of
Diabetes
8
CytoAntioxidantā„¢ Discovery Antioxidant
9
CytoHormoneā„¢ Discovery Product for treatment of hormonal disorders
Selectivity and MOA
ā€¢ Preclinical studies in Glioblastoma Multiforme and other
cancer cell types have demonstrated that CytoregĀ® has
high specificity and selectivity in targeting and inhibiting
cancer growth, as well as inducing selective apoptosis.
ā€¢ Mechanisms of action studies have also been performed
to understand how CytoregĀ® kills cancer cells. These
studies have demonstrated that CytoregĀ®: 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
ā€¢ A targeted therapy with multiple
mechanisms of action.
ā€¢ Demonstrated potential to reduce
tumor mass and/or stops tumor
growth or even destroys the tumor.
ā€¢ Favorable side effect profile, as
demonstrated in human
compassionate use program and in
preclinical studies performed to date.
ā€¢ Very low manufacturing costs.
Clinical Development Plan &
Regulatory Strategy
ā€¢ The Company expects that CytoregĀ® 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.
ā€¢ By focusing on these indications, CytoregĀ® will be a candidate
for Fast Track and Orphan Drug designations, and potentially
accelerated approval by US Food & Drug Administration
(USFDA).
ā€¢ 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.
ā€¢ If Funding is sufficient we may choose to initiate Clinical Trials
directly in the USA.
Intellectual Property
ā€¢ Cytorex believes the Companyā€™s intellectual property
(IP) position is secure. The Company has one issued
patent (US patent 7,141,251, ā€œPharmacologically
Active Strong Acid Solutionsā€) containing over 70
claims related to composition and therapeutic use.
ā€¢ Cytorex has developed a detailed patent prosecution
strategy to further enhance its IP position in the US
and worldwide. Cytorexā€™ IP estate has been reviewed
by Mr. Michael Keller, Esq. Mr. Keller has over 20
yearsā€™ experience prosecuting biomedical drug,
diagnostic and device patents.
Management Team
ā€¢ Prof. David Martucci, Chairman, President, Chief
Executive Officer and Chief Scientific Officer
ā€¢ Mr. William Jimenez, Director, Vice-President,
Treasurer and Chief Financial Officer
ā€¢ Mr. Carlos M. Garcia, Director, Secretary & Chief
Operations Officer
ā€¢ Mr. Ramon Alvarez, Business Development
Director
Key Advisors
ā€¢ Dr. Kris Dhandapani, Scientific Consultant
ā€¢ Mr. Michael J. Keller, Intellectual Property
Attorney
Scientific Committee
ā€¢ 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.
ā€¢ Dr. James Kumi-Diaka, DVM, PhD, Prof. of Cancer Biology (Florida
Atlantic University, Davie FL). Research Interest: Molecular Biology &
Apoptosis.
ā€¢ Dr. Manzur Hassanhi, MD, Professor of Immunology (University of
Zulia, Venezuela). Research Interest: Clinical Oncology.
ā€¢ Dr. Nelson VicuƱa, MD, Professor of Toxicology (University of los
Andes, Merida, Venezuela), Research Interest: Toxicology &
Pharmacology
ā€¢ Dr. Paula Durante, PhD, Biological Research (Private Consulting)
Research Interest: Physiology and Cellular Biochemical Mechanisms
ā€¢ Dr. Rosa de JesĆŗs, 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. CytoregĀ®, the Companyā€™s lead drug candidate, is currently in preclinical development for various cancers.
  • 3. Market Overview ā€¢ In 2007, worldwide sales of cancer therapies totaled USD $42.2 billion. ā€¢ Within the 7 major markets (US, Japan, France, Germany, Italy, Spain, and the United Kingdom), sales amounted to USD $34.3 billion. ā€¢ 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 ā€¢ Cytorex intends to initially focus development efforts of CytoregĀ® on cancer types with high levels of unmet need: Glioblastoma Multiforme (grade IV brain tumor); pancreatic cancer; and metastatic melanoma. ā€¢ CytoregĀ® 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 ā€¢ 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. ā€¢ CytoregĀ® is Cytorex lead drug candidate and is the primary focus of this presentation. ā€¢ CytoregĀ®, a novel cancer therapeutic candidate, is a formulation of balanced acids, where hydrofluoric acid (HF) is the key active ingredient. ā€¢ CytoregĀ® may be used to treat several types of cancers, including solid tumors and hematological malignancies.
  • 6. Portfolio PRODUCT STAGE APPLICATION 1 Cytoregā„¢: 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 CytoregUNOā„¢ 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 CytoCardioā„¢ Discovery Product for treatment of hypertension 4 CytoKStones ā„¢: Discovery Product for treatment of Kidney Stones 5 CytoNeuroSysā„¢ Discovery Product for treatment of MS, Alzheimerā€™s, Parkinsonā€™s, and chronic diseases like epilepsy. 6 CytoOSā„¢ Discovery Product for treatment of Otosclerosis 7 CytoDiabetā„¢ Discovery Product for treatment/regulation of Diabetes 8 CytoAntioxidantā„¢ Discovery Antioxidant 9 CytoHormoneā„¢ Discovery Product for treatment of hormonal disorders
  • 7. Selectivity and MOA ā€¢ Preclinical studies in Glioblastoma Multiforme and other cancer cell types have demonstrated that CytoregĀ® has high specificity and selectivity in targeting and inhibiting cancer growth, as well as inducing selective apoptosis. ā€¢ Mechanisms of action studies have also been performed to understand how CytoregĀ® kills cancer cells. These studies have demonstrated that CytoregĀ®: 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 ā€¢ A targeted therapy with multiple mechanisms of action. ā€¢ Demonstrated potential to reduce tumor mass and/or stops tumor growth or even destroys the tumor. ā€¢ Favorable side effect profile, as demonstrated in human compassionate use program and in preclinical studies performed to date. ā€¢ Very low manufacturing costs.
  • 9. Clinical Development Plan & Regulatory Strategy ā€¢ The Company expects that CytoregĀ® 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. ā€¢ By focusing on these indications, CytoregĀ® will be a candidate for Fast Track and Orphan Drug designations, and potentially accelerated approval by US Food & Drug Administration (USFDA). ā€¢ 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. ā€¢ If Funding is sufficient we may choose to initiate Clinical Trials directly in the USA.
  • 10. Intellectual Property ā€¢ Cytorex believes the Companyā€™s intellectual property (IP) position is secure. The Company has one issued patent (US patent 7,141,251, ā€œPharmacologically Active Strong Acid Solutionsā€) containing over 70 claims related to composition and therapeutic use. ā€¢ Cytorex has developed a detailed patent prosecution strategy to further enhance its IP position in the US and worldwide. Cytorexā€™ IP estate has been reviewed by Mr. Michael Keller, Esq. Mr. Keller has over 20 yearsā€™ experience prosecuting biomedical drug, diagnostic and device patents.
  • 11. Management Team ā€¢ Prof. David Martucci, Chairman, President, Chief Executive Officer and Chief Scientific Officer ā€¢ Mr. William Jimenez, Director, Vice-President, Treasurer and Chief Financial Officer ā€¢ Mr. Carlos M. Garcia, Director, Secretary & Chief Operations Officer ā€¢ Mr. Ramon Alvarez, Business Development Director
  • 12. Key Advisors ā€¢ Dr. Kris Dhandapani, Scientific Consultant ā€¢ Mr. Michael J. Keller, Intellectual Property Attorney
  • 13. Scientific Committee ā€¢ 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. ā€¢ Dr. James Kumi-Diaka, DVM, PhD, Prof. of Cancer Biology (Florida Atlantic University, Davie FL). Research Interest: Molecular Biology & Apoptosis. ā€¢ Dr. Manzur Hassanhi, MD, Professor of Immunology (University of Zulia, Venezuela). Research Interest: Clinical Oncology. ā€¢ Dr. Nelson VicuƱa, MD, Professor of Toxicology (University of los Andes, Merida, Venezuela), Research Interest: Toxicology & Pharmacology ā€¢ Dr. Paula Durante, PhD, Biological Research (Private Consulting) Research Interest: Physiology and Cellular Biochemical Mechanisms ā€¢ Dr. Rosa de JesĆŗs, 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: