IR Biosciences — Investor Presentation (March 2008)
40 slides from IR Biosciences's investor presentation, Mar 28, 2008
Slide 1: IR BioSciences Holdings, Inc. Investor Relations March 2008
[| !mmuneRegen IR BIOSCIENCES HOLDINGS, INC. Investor Relations March 2008
Slide 2: Company Overview
Company Overview Biotechnology product development company e Founded in 2002 e Capitalized and confident in our strategy for generating revenue through licensing agreements
Slide 3: Mission
Mission We are focused on advancing products that regenerate or strengthen the human immune system, in part, through stimulation of adult stem cells. The Company is working to capitalize on its drug candidates by continuing our own development programs and_ simultaneously seeking to license product
Slide 4: Management Team
Management Team Michael K. Wilhelm, Chief Executive Officer and Board Member Mr. Wilhelm has over 14 years of experience in the financial industry, working closely with early stage companies. He serves as a liaison to government officials at the U.S. Homeland Security Office as well as the country’s
Slide 5: Outside Board Members
Outside Board Members Robert J. Hariri, M.D., Ph.D. Dr. Hariri is CEO of Celgene Cellular Therapeutics, a division of Celgene Corporation, Warren, NJ. Celgene is a world leader in human cellular and tissue therapeutics, highly successful entrepreneur, Dr. Hariri has extensive experience in the capit
Slide 6: Financial History
Financial History Initial Funding of $1.0MM from insiders e July, 2003 Reverse Merger e October, 2004 PIPE (Private Investment in Public Equity) - $2.0MM e March, 2005 Warrant Tender Offer - $1.2MM e December, 2006 PIPE - $3.6MM e January, 2008 Convertible Debenture - $3.0MM
Slide 7: Developmental History
Developmental History e Founded by an_- experienced _ life-sciences executive and University of Arizona scientists in 2002 e Early studies funded by the U.S. Air Force demonstrated the ability to reduce lung tissue inflammation e Subsequent NIH-guided experiments showed protection from lethal radiat
Slide 8: Current Status
Current Status e Five issued patents e At least 60 pending patent applications e« 10 pending U.S. utility patent applications e 10 pending U.S. provisional applications « 4 pending international patent applications e 37 pending foreign patent applications e Recent studies have confirmed an _ underly
Slide 9: Mechanism
Mechanism Homspera activates a receptor in the cell membrane to regulate expression of different genes Homspera wa kth TN Ga Gene Regulation Intra-Cellular F ol Mp Signaling w Receptor Events
Slide 10: What are Stem Cells?
What are Stem Cells? Adult co Stem Cell Undifferentiated cells able to form all cells in the body e Directed by your e) Precursor Cell body to form t fo specific cells for © © © © © tissues and organs Blood Stem Cell | onmeyetem rele | ¢ The human immune y y Nerve Bone Muscle Other system relies on
Slide 11: Immune System Development
Immune System Development Hematopoietic e Cells in the Stem Cell rz, immune system are produced from Blood-Forming (Hematopoietic) oo Myeloid Stem Cells wens ® @= zt e Hematopoietic Gaaphaia Myeloid stem cells provide _ blast Biase a well-understood model for stem cell differentiation @ ©) @ * @ @ P
Slide 12: Stem Cell Research
Stem Cell Research Homspera e Increased stem cell differentiation into cells that are required to regenerate or strengthen the human immune system e Enhanced production of: The em Cell 1) White blood cells (*) o- (fight infection) Red Blood 4, “ a) Granulocytes Cells ee b) Macrophages shite © Platel
Slide 13: Hematopoietic Stem Cell Disorders & Indications
Hematopoietic Stem Cell Disorders & Indications Hematopoietic Cell Disorders Histiocytic Disorders Aplastic Anemia (Severe) Familial Erythrophagocytic Lymphahistiocytosis Fanconi Anemia Histiacytosis-X Congenital Dyserythropoietic Anemia Hemophagacytosis Paroxysmal Nocturnal Hemoglobinuria (PNH) ure
Slide 14: Stem Cell Market Value
Stem Cell Market Value U.S. Government funding for stem cell research has increased 3-fold from 2004 to 2005 ($210 million to $630 million) + The market for G-CSF (treatment for decreased white blood cell counts) was approximately $4.4 billion in 2006 2 Sale of Amgen’s G-CSF drugs (Neupogen® and Neu
Slide 15: Potential Homspera Clinical Applications
Potential Homspera Clinical Applications Vaccine Adjuvant e Infectious Disease e Radiation Injury e Wound Healing
Slide 16: Vaccine Adjuvant
Vaccine Adjuvant Background Vaccines are e Adjuvants are traditionally PR agen Oe disease components of vaccines e Their purpose is to stimulate the immune system above that of vaccine antigen alone e Enhance white blood cell infection- fighting activity e Potentially reduce the amount of vaccine an
Slide 17: Vaccine Adjuvant
Vaccine Adjuvant Homspera e Increased vaccine-induced antibodies against the influenza virus compared to vaccine alone in small animal studies e Increased survival following avian-influenza infection in small animals when administered with an influenza vaccine Management believes that antibodies and
Slide 18: Vaccine Adjuvant
Vaccine Adjuvant Potential e Typical vaccine manufacturing is an expensive and time-consuming process e Current manufacturing capacity is not sufficient to support influenza vaccine production for a pandemic e Successful development of new adjuvants will help reduce the amount of vaccine required pe
Slide 19: Vaccine Adjuvant Market
Vaccine Adjuvant Market Commercial e GSK acquired Corixa’s MPL® adjuvant for $346 million in 2005 e The global vaccine market is expected to reach $21.05 billion by 2010 ! Biodefense e BioShield authorized $5.6 billion over 10 years for procurement 2 e $3.5 billion ? 27 contracts and 2 grants for va
Slide 20: Infectious Disease: Influenza
Infectious Disease: Influenza Background H~ /N Hemagglutinin (H) - helps the virus attach to and infect cells Virus Neuraminidase (N) - important Particle for virus replication Influenza strains vary because of different H and N combinations that change the virus (ex. H5N1, H3N2, H1N1) Seasonal vs.
Slide 21: Infectious Disease: Influenza
Infectious Disease: Influenza Homspera Results Reduction of virus particles in the lung and nasal passage Intuenze virus Reduction of illness-related symptoms Increased survival Greater efficacy than Tamiflu® « Lower levels of lung inflammation with Homspera compared to Tamiflu treatment Lungs »* Ho
Slide 22: Infectious Disease: Anthrax
Infectious Disease: Anthrax Background e Bacteria (Bacillus anthracis) e Inhalation of anthrax spores often leads to fatal infection (~80% mortality rate) e The U.S. Government recognizes anthrax as a potential bioterrorism threat e Vaccines exist for preventing anthrax infection e Vaccines won't be
Slide 23: Infectious Disease: Anthrax
Infectious Disease: Anthrax Homspera Results e Prophylactic activity - increased survival in small animals pre-treated with Homspera and then exposed to anthrax e Therapeutic activity - increased survival in small animals exposed to anthrax and then given Homspera 4 or 24 hours after exposure e Trea
Slide 24: Infectious Disease Market
Infectious Disease Market e Tamiflu (Roche) manufacturing capabilities and market !: 2006 - manufacturing capacity at 400 million treatment courses (equivalent to 4_ billion tablets worth approximately $7.8 billion if sold entirely to governments for pandemic use) e Anthrax Program ?: 2007 - up to $
Slide 25: Radiation Injury
Radiation Injury Background e Therapies are needed to protect people against radiation injury (accidental or terrorist attacks) e Without treatment, survival and recovery is dependent on the amount of radiation absorbed e Mortality rates approach 50% when blood and stem cells are severely compromise
Slide 26: Radiation Injury
Radiation Injury Homspera Results e Increased survival of small animals exposed to radiation white blood _ (lethal & sub-lethal doses) aN e Treatment is effective after exposure to radiation cells e WBC numbers increased in treated animals Management believes Homspera restores WBCs by stimulating ad
Slide 27: Radiation Market
Radiation Market e Funding for biodefense spending (including protection against CBRN threats) was about $6 billion in 2004 1 e US. homeland — security-related R&D totaled $5.2 billion in 2007 and included cost for research of CBRN threats + e In early 2008 Osiris Therapeutics, Inc. secured a DOD co
Slide 28: Wound Healing
Wound Healing Background Hair Epidermis Epidermis The skin is comprised of 2 main layers: 7
Slide 29: Wound Healing
Wound Healing Homspera tae thy ee Direct cell cise Indirect cell stimulation stimulation Epidermis Keratinocytes Langerhans’ cells y Neutrophils 1 © Macrophages y pei wStemeells. Mast Cells a Dermis Fibroblasts
Slide 30: Wound Healing
Wound Healing Phases of Wound Healing: ug 8 2 a Ej 3 : z
Slide 31: Wound Healing
Wound Healing Homspera e Increased proliferation of fibroblasts in vitro (cell culture) e Stimulated hematopoietic stem cell activity Peer-reviewed literature suggests e Normalization of inflammatory response in early phase of wound healing e Improved migration of epidermal and dermal cell types imp
Slide 32: Wound Healing Market
Wound Healing Market e Projected global wound care market for 2010 is $15.3 billion (driven by sealants, growth factors and skin replacements) ! e Global wound care market was $7.2 billion in 2006 2 e U.S. market for tissue-engineered — skin replacements/substitutes and active wound repair modulator
Slide 33: Research Conclusions
Research Conclusions The stimulatory effects observed Joserare on adult hematopoietic stem cells lead Management to believe © Homspera regenerates and - strengthens the immune system, Hematopointia thereby contributing to the effectiveness of treatment in the J following indications: Immune cell pro
Slide 34: Licensing Strategy
Licensing Strategy « It can take over $1 billion dollars and 12-15 years to take a drug from pre-clinical indications to market 4 « Large pharmaceutical companies are more efficient at marketing and_ selling than investigating new compounds « ImmuneRegen can dramatically speed its path to profitabil
Slide 35: Licensing Strategy
Licensing Strategy Homspera { 1 | Formulation 1 Formulation 2 Formulation 3 Mode of Mode of Mode of Administration 1 Administration 2 Administration 3 | | { Viprovex® Radilex® Others - TBD Out-licensing will involve different formulations that depend on the potential indication and administration ro
Slide 36: Licensing Transaction
Licensing Transaction e Recent pre-clinical deals range in value from $2 million to $1.4 billion e Atypical license transaction includes: e Initial one-time payment for IP rights e On-going payments for developmental, regulatory and/or commercial milestones e Royalties for commercialization and opti
Slide 37: Recent Pre-Clinical License Deals
Recent Pre-Clinical License Deals e December 2007 - Addex Pharmaceuticals entered into an exclusive collaboration and license agreement with Merck for $3 million up front ($100 million available upon milestone completion) e February 2008 - Neuralstem sold an option for $2.5 million to CJ CheilJledan
Slide 38: Co-Development Deals
Co-Development Deals Wp DERSITE es! cl
Slide 39: Study Partners
Study Partners Mens Armed Forces, es ait ® Ipveiic aa desea S)UMDN) _ pacificNorthwest National Laboratory Ceeere: GES} GL EMO ete wrtnerst VY ” SOUTHERN RESEARCH DE oie Ap: ._—___ai Gane (Q Dass ay ELOPMENT SERVICES COMPANY : EPITWMICS Z - Ee)
Slide 40: For any questions, please contact:
For any questions, please contact: e Michael Wilhelm, CEO mwilhelm@immuneregen.com e Dr. Hal Siegel, CSO hsiegel@immuneregen.com e John Fermanis, CFO jfermanis@immuneregen.com
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