Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Adeona Pharmaceuticals — Investor Presentation (January 2011)
25 slides from Theriva Biologics's investor presentation, Jan 10, 2011
Slide 1: Adeona Pharmaceuticals, Inc.
Adeona Pharmaceuticals, Inc. Innovative medicines for serious central nervous system diseases NYSE AMEX: AEN James S. Kuo, MD, MBA. Chairman and CEO ikuo@adeonapharma.com January 2011 adeona
Slide 2: Forward-Looking Statement
Forward-Looking Statement This presentation includes forward-looking statements on Adeona’s current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates,"
Slide 3: Corporate Profile
Corporate Profile * Focus on central nervous system diseases ¢ License product candidates with indications of clinical efficacy * Seek to establish large pharma collaborations * Success with $17.5 million Meda deal for fibromyalgia ¢ Near-term prescription medical food candidate for Alzheimer’s dise
Slide 4: Management Team
Management Team James S. Kuo, M.D., M.B.A. PENN Medicine Wharton Position Chairman, President, Chief Executive Officer, Chief Financial Officer Experience David A. Newsome, M.D. Senior Vice President of Research and Development Julie A. Caudill, B.B.A. Vice President of Finance and Corporate Control
Slide 5: Pillars of Innovation
Pillars of Innovation Principles for successful research and development Focus on Test new Rigorous and serious central therapies in objective nervous system people, not third-party diseases animals reviews Intellectual Property Protection (adeona ;
Slide 6: Product Pipeline
Product Pipeline Innovative medicines for serious central nervous system diseases Medical Indication Product Candidate Prescription Medical Food Development Alzheimer’s disease and mild cognitive impairment Zinthionein (zinc cysteine) Pivotal clinical study Drug Development Multiple sclerosis Trimes
Slide 7: Zinc Deficiency Increases With Age
Zinc Deficiency Increases With Age Second most abundant trace element in humans (after iron) Responsible for over 300 important enzymes Hippocampal zinc levels are highest in brain (synaptic transmitter) Antagonizes/blocks chronic copper toxicity ‘Source: Kogirima M (2009) 120 a . 20 0 eo 0 100 Age
Slide 8: Loss of Zinc, ZnT3 and NMDA Receptors
Loss of Zinc, ZnT3 and NMDA Receptors Decline in synaptic zinc in age and Alzheimer’s disease ¢ Neuronal zinc decreases with age * Decrease in zinc is more pronounced in Alzheimer’s disease * Beta-amyloid plaques further sequester available zinc — ee ~ oo on - ne (a3 7 AB oligomer °° ey & Presynapti
Slide 9: Alzheimer's Disease/Mild Cognitive Impairment
Alzheimer’s Disease/Mild Cognitive Impairment Product candidate — Zinthionein * Treat zinc deficiency in Alzheimer’s disease and mild cognitive impairment patients * Limitations of zinc therapy — Gastric irritation (tolerability) — Dosing frequency (bioavailability) * Proprietary, gastroretentive, s
Slide 10: Zinthionein Pivotal CopperProof-2 Clinical Study
Zinthionein Pivotal CopperProof-2 Clinical Study For management of Alzheimer’s disease/mild cognitive impairment First controlled trial of zinc for Alzheimer’s disease 60-patient, randomized, double-blind, placebo-controlled study at 3 clinical sites in Florida 6-month dosing comparing cognition, MM
Slide 11: Timeline - CopperProof-2 Clinical Study
Timeline - CopperProof-2 Clinical Study For management of Alzheimer’s disease/mild cognitive impairment IRB approval November 2009 Initiation of patient dosing January 2010 Completion of Part 1 April 2010 Completion of enrollment Part 2 September 2010 Anticipated completion Part 2 End of March 2011
Slide 12: Prescription Medical Food
Prescription Medical Food Specialty pharmaceutical Legislation defined in Orphan Drug Act Medical food for “dietary management” sold by prescription Ingredients must be GRAS (Generally Recognized As Safe) Premarket review and approval by FDA not required Private insurance reimbursement is generally
Slide 13: Historical Efficacy of Estriol
Historical Efficacy of Estriol Hormone produced by placenta; possibly linked to fetal immune privilege * Estriol has been approved in Europe and Asia for 40 years for treating symptoms of menopause but never approved in the U.S. for any indication fi * PRegnancy In Multiple Sclerosis (PRIMS) study f
Slide 14: Multiple Sclerosis
Multiple Sclerosis Product candidate — Trimesta * Trimesta developed by — Rhonda Voskuhl, M.D., Professor, UCLA Department of Neurology — Jack H. Skirball, Chair for Multiple Sclerosis Research, Director, UCLA Multiple Sclerosis Program * Completed an investigator-initiated, 10-patient, 22-month, si
Slide 15: Clinical Evaluation of Trimesta
Clinical Evaluation of Trimesta Phase II clinical trial at 15 centers Randomized, double-blind, placebo-controlled clinical trial in 150 female patients with relapsing-remitting multiple sclerosis * Comparing relapse rates with 8 mg of Trimesta taken daily over 2 years versus matching placebo with C
Slide 16: Trimesta — Future Plans
Trimesta — Future Plans Evaluate the potential to treat cognitive decline in multiple sclerosis * Cognitive loss affects about 50-65% of multiple sclerosis patients — Currently, there is no FDA-approved therapy * Completed investigator-initiated clinical trial showed a 14% improvement in PASAT (Pace
Slide 17: Corporate Partnership with Meda
Corporate Partnership with Meda Effirma (flupirtine) for fibromyalgia attracted large pharma collaboration * $17.5 million corporate partnership with Meda announced on May 7, 2010 — Meda assumes all future development costs — Adeona eligible to receive up to a potential $15 million in milestone paym
Slide 18: Fibromyalgia Market Opportunity
Fibromyalgia Market Opportunity Commercial potential for Effirma * Chronic and debilitating condition characterized by widespread pain and stiffness throughout body, accompanied by severe fatigue, insomnia and mood symptoms — Affects 2-4% of the population worldwide, including an estimated 4 million
Slide 19: Age-Related Macular Degeneration
Age-Related Macular Degeneration Opportunity for zinc-based therapies * Leading cause of blindness among persons 65 years or older affecting 10 million Americans ¢ Zinc and zinc antioxidant nutritional supplementation are the only scientifically supported therapies — Newsome et a/ 1988 reported stud
Slide 20: Age-Related Macular Degeneration
Age-Related Macular Degeneration Product candidate — ZincMonoCysteine counsozs * Completed an 80-patient, randomized, double-blind, placebo- controlled clinical trial for the treatment of dry age-related macular degeneration * Two-arm clinical trial comparing 25 mg of ZincMonoCysteine versus matchin
Slide 21: Rheumatoid Arthritis
Rheumatoid Arthritis Product candidate — dnaJP1 (hsp peptide) Epitope-specific oral immunotherapy 15-mer heat shock protein-derived peptide that was previously identified as a contributor of T cell-mediated inflammation in rheumatoid arthritis Completed a 160-patient, multi-center, randomized, doubl
Slide 22: Intellectual Property
Intellectual Property * Selected issued patents — Trimesta (estriol) = U.S. Patent 6,936,599, issued August 30, 2005 — Effirma (flupirtine) = U.S. Patent 6,610,324, issued August 26, 2003 — ZincMonoCysteine (zinc-monocysteine) = U.S. Patent 7,652,161, issued January 26, 2010 = U.S. Patent 7,164,035,
Slide 23: Adeona Clinical Laboratory
Adeona Clinical Laboratory Secondary corporate strategy * Clinical reference laboratory located in the Chicago area * CLIA-certified to perform high complexity chemistry and microbiology laboratory tests * Exclusively offers the proprietary CopperProof test to identify risk of zinc deficiency and ch
Slide 24: Financial Snapshot
Financial Snapshot Current Price: $1.50 52 Week Range: $0.70 - $2.70 Market Capitalization: ~$37 million Average Volume (3 months): 241,743 Shares Outstanding: 23.2 million Public Float: “15.6 million Approximately $3.1 million cash on hand as of October 31, 2010 Stock info as of 1/5/2011 and share
Slide 25: Investment Opportunity
Investment Opportunity Scientific expertise in serious central nervous system diseases Potential blockbuster prescription medical food and drug candidates in clinical development pipeline Multiple shots at goal Significant grant funding received Recent corporate deal and quarterly profit indicates t
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