IR Biosciences — Shareholder Meeting (June 2008)
56 slides from IR Biosciences's shareholder meeting presentation, Jun 24, 2008
Slide 1: Annual Shareholder's Meeting
Exhibit 99.1 J ImmuneRegen oe IR BIOSCIENCES HOLDINGS, INC. Annual Shareholder's Meeting Napa, CA June 2008 Michael Wilhelm Hal Siegel, Ph.D. Kasey Benson, Ph.D.
Slide 2: Safe Harbor
Safe Harbor Statements about ImmuneRegen's future expectations, including statements about the potential use and scientific resuks for ImmuneRegen's drug candidates, science and technology, and all other statements in this presentation other than historical facts, are “forward-looking statements" wi
Slide 3: Mission
Mission We are a biotechnology company, focused on advancing products that regenerate or strengthen the human immune system, in part, through stimulation of adult stem cells. We are working to capitalize on our drug candidates by continuing our own development programs and_ simultaneously seeking to
Slide 4: Management Team
Management Team Michael K. Wilhelm, Chief Executive Officer and Board Member \Michae! K. Wilhelm has been a Co-founding member, cur President and Chief Executive Officer ag well as & member of our Board of Directors since December 2002. He has served as Managing Director of Foresight Capital Corpora
Slide 5: Outside Board Members
Outside Board Members De. Gordon hes served on our Board of Directors since May 2007, He curently serves as Presider and CEO of Inmuroticloges orporeno, a fom sive Blomctnobgy company tate founded n/2007, fart his work af MmunGoioUgKs Coporaion or. Gots Served os Posie, CEO and ssa Drevtor of VaxGen
Slide 6: Scientific Advisory Board
Scientific Advisory Board Dr. John Dann, M.D., D.D.S., craduate of Harvard University Dental Schoo! ‘and Washington University Medical School, Board Certified maxillofacial and craniofacial surgeon. Dr. Jeffrey Friedman, M.D., pipiomat, american Board of Cosmetic Surgery, American Board of Otolaryng
Slide 7: Financial History
Financial History IR BioSciences Holdings, Inc. (OTCBB:IRBO) e 2002: Initial funding of $1.0 million from original investors « July 2003: Reverse merger « October 2004: PIPE (Private Investment in Public Equity) - $2.0 million « March 2005: Warrant tender offer - $1.2 million « December 2006: PIPE -
Slide 8: Developmental History
Developmental History e Founded by an_ experienced _ life-sciences executive and University of Arizona scientists in 2002 « Early studies funded by the U.S. Air Force demonstrated the ability to reduce lung tissue inflammation (jet fuel fumes, diesel exhaust, side-stream cigarette smoke) « Subsequen
Slide 9: Current Status
Current Status « Five issued U.S. and foreign patents e At least 69 pending patent applications including: * 10 pending U.S. utility patent applications + 17 pending U.S. provisional applications + 4 pending international patent applications + 38 pending foreign patent applications « Recent stem cel
Slide 10: Homspera® Formulations
Homspera® Formulations Homspera | J Y 1 Formulation 1 Formulation 2 Formulation 3 Mode of Mode of Mode of Administration 1 Administration 2 Administration 3 | | { Viprovex® Radilex® Others - TBD
Slide 11: Receptor Specificity
Receptor Specificity Homspera © (arg Pro Lys Pro Gin Gin Phe Phe Sar Leu Met(0,)-NH,) XX = (neurokinin-1 receptor) Substance P © (Arg Pro Lys Pro Gin Gin Phe Phe Gly Leu Met-NH,) ae imp NK-1R ‘inp NK-2R iE NK-3R
Slide 12: Peptide Degradation
Peptide Degradation e Homspera e Substance P Ext Mul: e e Membr -be id peptidases De 6 a! s'peptidases Cy i @ peptidases @ 6 Homspera is more resistant to proteolytic degradation
Slide 13: Mechanism
Mechanism Homspera activates a receptor in the cell membrane to regulate expression of different genes Homspera nN Infre-Callular gi a, Signaling Events
Slide 14: Mechanism of Action
Mechanism of Action Homspera
Slide 15: Mechanism of Action
Mechanism of Action Supporting Experiments * NK1R-mediated calcium elevations intracellularly, likely via G-proteins coupled to AC and/or PLC (major and minor receptor subtypes) * RT-PCR using mRNA isolated from a RAW 264.7 murine macrophage cell line shows elevations in mRNA for cytokines, interleu
Slide 16: What are Stem Cells?
What are Stem Cells? Adult « Undifferentiated Stem Cell cells that become various cell types (e)) Piscursor Gait depending on the organ or system in 4 \ which they reside () (2) (<3) © (2) Blood Stem Cell Other Stem Cells * The human 1 1 Lor ft immune system weieuen_ age Nerve Bone Musde Other relie
Slide 17: Immune System Development
Immune System Development Hematopoietic * Cells in the Stem Cell = immune system are produced from Blood-Forming 2 (Hematopoietic) —tymphoia Myeloid o A ES gs « Hematopoietic Lymohoid Nae stem cells provide a well-understood model for stem > cell differentiation CY © @ *@ Tells Bells ace ©. RedBlood
Slide 18: Stem Cell Research
Stem Cell Research Homspera Findings + Increases stem cell differentiation into cells that are required to regenerate or strengthen the human immune system * Enhances production of the following precursors: 1. White blood cells (fight infection) tem Cell a. Granulocytes oe Q- b. Macrophages Pres ‘ B
Slide 19: Homspera Stimulates Stem Cell Differentiation
Homspera Stimulates Stem Cell Differentiation: Granulocyte/ Macrophage Precursors CFU-GM 240 * Human bone marrow: mononuclear cells a Ee, i Bi 200 2; = 2 replicates/progenitor 3 + Progenitor assayed £180 inatidualy ° 8 1600 rs o 140 oe s 120 ae a 80
Slide 20: Hematopoietic Stem Cell Indications
Hematopoietic Stem Cell Indications ysplastic/Myeloprolifertive Disorders Inherited MetabolicDisorders Inherited Immune System Disorders te Myeofibas ‘arencleukedystoohy ‘GhronieGranuom ous Disease ager Myeloid Metaolasa(Myeohibrosis) Fucoscoss Congontatieutropena vias, ‘Gaucher Disease {eukecyte Ac
Slide 21: Stem Cell Market Value
Stem Cell Market Value U.S. Government funding for stem cell research 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 Neulast
Slide 22: Potential Homspera Clinical Applications
Potential Homspera Clinical Applications Vaccine Adjuvant Infectious Disease Radiation Damage Wound Healing
Slide 23: Vaccine Adjuvant
Vaccine Adjuvant Background « Adjuvants are traditionally components of vaccines « Their purpose is to stimulate the immune system above that of vaccine antigen alone « Enhance immunoreactivity « Potentially reduce the amount of vaccine antigen required (antigen-sparing)
Slide 24: Adjuvant Activity
Adjuvant Activity Viprovex Treatment « Homotypic and heterotypic antibody titers are increased « Increased survival rates in vaccinated animals challenged with highly pathogenic H5N1 influenza « Humoral and cell-mediated* immune responses are enhanced e Drug delivery techniques include intranasal an
Slide 25: Adjuvant: Viprovex increases antibody response
Adjuvant: Viprovex increases antibody response Homotypic response: H1N1 (Spanish flu) antibodies in H1N1-vaccinated mice 250000 —*HIN1 -® HIN1+ Viprovex 200000 150000 100000 50000 i © 0 2 4 6 8 10 H1N1 Antibody Titer Weeks post-injection
Slide 26: Adjuvant Activity
Adjuvant Activity “The NK1R agonist neuropeptide Sar®, Met (O,)!!-Substance P meets the requirements of a Thi-Tc1-biasing adjuvant while also favoring the elicitation of Ab responses.” « Subcutaneous administration independent of intradermal gene-gun delivered construct Elicits Tc1- and Th1-biased i
Slide 27: Vaccine Adjuvant
Vaccine Adjuvant Potential « Typical vaccine manufacturing is an expensive and time-consuming process « Current manufacturing capacity is not sufficient to support influenza vaccine production for a pandemic « Successful development of new adjuvants will help to reduce the amount of vaccine required
Slide 28: Vaccine Adjuvant Market
Vaccine Adjuvant Market Commercial * GSK acquired Corixa’s MPL® adjuvant for $346 million in 2005 + The global vaccine market is expected to reach $21.05 billion by 2010 ! Biodefense * BioShield authorized $5.6 billion over 10 years for procurement 2 * $3.5 billion? 27 contracts and 2 grants for vac
Slide 29: Infectious Disease: Influenza
Infectious Disease: Influenza Background HA, ZN + Hemagglutinin (H) - helps the virus attach to and infect cells + Neuraminidase (N) - important for virus replication + Influenza strains vary because of different H and N combinations that change the virus (ex. HSN1, H3N2, H1N1) + Seasonal vs. pandem
Slide 30: Infectious Disease: Influenza
Infectious Disease: Influenza Viprovex Findings in Animals + Reduction of virus particles in the lung and nose + Reduction of illness-related symptoms (weight loss and hypothermia) + Increased survival of infected animals + Greater efficacy than Tamiflu® Lungs ante + Lower levels of lung inflammatio
Slide 31: Infectious Disease: Influenza
Infectious Disease: Influenza Preliminary Results in an H5N1-infected Ferret Model « Viprovex decreased the magnitude of weight loss and hypothermia « Animals treated with Viprovex (n=4) were more active than corresponding controls (n=4) «None of the animals treated with Viprovex were observed to ha
Slide 32: Infectious Disease: Anthrax
Infectious Disease: Anthrax Background « Bacteria (Bacillus anthracis) « Inhalation of anthrax spores often leads to fatal infection (~80% mortality rate) « The U.S. Government recognizes anthrax as a potential bioterrorism threat « Vaccines exist for preventing anthrax infection « Vaccines won't be
Slide 33: Infectious Disease: Anthrax
Infectious Disease: Anthrax Viprovex Findings e Prophylactic activity - increased survival in animals pre-treated with Viprovex and then exposed to anthrax e Therapeutic activity - increased survival in animals exposed to anthrax and then given Viprovex 4 or 24 hours after exposure
Slide 34: Anthrax: Viprovex increases survival
Anthrax: Viprovex increases survival Dose-dependent increase in survival of Anthrax- infected mice pre-treated with Viprovex 100 rT" OT] 80 60 + control —— te 300UM Viprovex © 1000uM Viprovex % Survival 20
Slide 35: Infectious Disease Market
Infectious Disease Market « 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 2: 2007 - up to $4
Slide 36: Radiation
Radiation Background « Therapies are needed to protect people against radiation exposure (accidental or terrorist attacks) « Without treatment, survival and recovery is dependent on the amount of radiation received « White blood cells (WBCs) are very sensitive to radiation exposure and damage can le
Slide 37: Radiation Dose Effects
Radiation Dose Effects Dose Range] Prodrome Clinical Manifestations Prognosis (cy) (Untreated) lo.s1.0 rare) ISight decreasein blood counis _ |Survivalin vast majority. 1.020 |Mild-> Moderate. |Eary sans ofbbone marow toxicity _|survival>90% 203.5 [Moderate IMocierate > Severe bone marrow _ |Surviva
Slide 38: Radiation
Radiation Radilex Findings * Increased survival of small animals exposed to lethal radiation levels © Treatment is more effective after exposure to radiation ees ¢ WBC numbers increase in treated animals e Data suggests Radilex could counteract the neutropenia often associated with chemotherapy drug
Slide 39: Radilex promotes survival of lethally-irradiated mice
Radilex promotes survival of lethally-irradiated mice ‘0 io a gd See “= Control_--WithRadilex a” 7.75Gy+/-50uMRadilex Percent Survival 885 8 8B Days Post-Irradiation
Slide 40: Radilex increases WBCs in irradiated small animals
Radilex increases WBCs in irradiated small animals 10000 @ Irradiated Control s000 © Homspera Pre G Homspera Post 2 | Zoo 0 © & 4000 i ” I 2000 0 || i = 24 Hours 48 Hours 96 Hours Hours Post-Radiation Exposure
Slide 41: Radilex: Potential role in cancer therapy
Radilex: Potential role in cancer therapy e Host hematopoiesis is stimulated e Tumors are reduced in vivo (B16 melanoma in mice) e Mitogenesis of cancer cell lines is not stimulated « Effectiveness of chemotherapeutic agents is maintained in vitro
Slide 42: Radiation Market
Radiation Market « Funding for biodefense spending (including protection against CBRN threats) was about $6 billion in 2004 + « U.S. homeland — security-related R&D totaled $5.2 billion in 2007 and included cost for research of CBRN threats + « In early 2008 Osiris Therapeutics, Inc. secured a DOD c
Slide 43: Wound Healing
Wound Healing
Slide 44: Wound Healing
Wound Healing Phases of Wound Healing:
Slide 45: Wound Healing
Wound Healing Peer-reviewed literature suggests + Normalization of inflammatory response in early phase of wound healing * Improved migration of epidermal and dermal cell types important for wound healing + Increased healing rate of wounds, including burns and diabetic ulcers + Reduced scarring Homs
Slide 46: Homspera accelerates wound closure
Homspera accelerates wound closure: in vivo porcine model = Homspera 10-4 M
Slide 47: Wound Healing Market
Wound Healing Market e “Collectively, chronic wounds cost the nation $20-25 billion a year, and acute or traumatic wounds add another $7-10 billion annually” + e Globally, the advanced wound care market was $7.2 billion in 2006 2 e U.S. market for tissue-engineered skin replacements/substitutes and
Slide 48: Research Conclusions
Research Conclusions The stimulatory effects observed on adult hematopoietic stem cells lead Management to believe Homspera regenerates and Hematopoietic strengthens the immune system, ‘stem calle thereby contributing to the i) effectiveness of treatment in the following indications: ammune cal 2 pr
Slide 49: Licensing Strategy
Licensing Strategy « It can take over $500 million and roughly 8-15 years to take a drug from pre-clinical indications to market + + Large pharmaceutical companies are more efficient at marketing and selling than investigating new compounds + ImmuneRegen can dramatically speed its path to profitabil
Slide 50: Recent Pre-Clinical License Deals
Recent Pre-Clinical License Deals e June 2008 - Novartis is purchasing antibiotics developer Protez Pharmaceuticals for $100 million, which could turn into $300 million if the new broad- spectrum antibiotic is a success e May 2008 - Emergent BioSolutions acquired VaxGen’s recombinant protective anth
Slide 51: Studies in Progress
Studies in Progress « Pharmacokinetics Radiation-induced neutropenia Stem cell mechanistic studies « Vaccine adjuvant « B16 cancer study « Wound healing dose ranging studies « Drug formulation and stability tests + Genotoxicity GLP studies (required for IND)
Slide 52: ImmuneRegen: Then...and Now
ImmuneRegen: Then...and Now Preliminary evid pulmonary anti-inflay activity Undeterminec therapeuticare lardization of inhalation parameters nent of analytical tools for pra detection in blood (MS, ELISA) mmiflu & Viprovex co- n effectiveness ications identified ind Healing,
Slide 53: Independent Consultants
Independent Consultants Dr. Cavagnaro is the President of Access B10, Boyce, VA, a consultancy specializing in science-based regulatory strategies and precinical product development Services to facilitate biomedical research and emerging technologies. She has over 25 years experience in biotech span
Slide 54: Co-Development Deals
Co-Development Deals CuRU DEDSITE BIOTECHNOLOGIES INC.
Slide 55: Study Partners
Study Partners Pacific Northwest National Laboratory (OD SOUTHERN RESEARCH GURU “metronome tse rn
Slide 56: For any questions, please contact:
For any questions, please contact: « Michael Wilhelm, CEO wilhelm@immuner .com « John Fermanis, CFO ifermanis@immuneregen.com * Dr. Hal Siegel, CSO ice « Dr. Kasey Benson, Scientific Director kbenson@immuneregen.com Thanks to the Science Team: Heidi Pinyerd & Chris Romano
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