cbli- april 1 2010

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    Investor PresentationApril 1, 2010

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    This presentation includes forward-looking statements and predictions, including

    statements about potential revenue-bearing transactions, the market potential of

    CBLIs technologies and product candidates, and the potential value of pipelineproducts. These statements represent the Companys judgment as of the date of this

    presentation and are subject to risks and uncertainties that could cause actual

    results of events to differ materially from those expressed in such forward-looking

    statements. In particular, CBLI faces risks and uncertainties that it may not be able

    to sustain its business model, that revenues may be lower or expenses higher than

    projected, that product sales may not increase, that development of product

    candidates in the Companys pipeline may not succeed or that commercialtransactions may not go forward as planned.

    Safe-Harbor

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    CBLI is developing two families of drugs:

    Protectans: selectively protect healthytissues from radiation damage

    Curaxins: kill tumor cells

    Mission

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    CBLI Summary

    IP

    Cleveland Clinic (CCF) Roswell Park Cancer Institute (RPCI)

    Partnerships

    Money raised from capital market $56 million Federal grants and contracts >$50 million

    Funding History

    Incorporated in June 2003 Spin-off from the Cleveland Clinic HQ - Buffalo, NY 36 full time employees (majority PhDs & MDs)

    ~16 sets of patent applications filed First CBLB502 US & European patents granted

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    CBLI Target Product Market Opportunities

    CBLB502: Protection from Acute Radiation Syndrome(ARS) >$500 million + annually

    CBLB502: Reduction of cancer treatment side effects~$20 billion market (70% of patients experience regimen-limiting

    toxicity )

    CBLB612: Stem cell induction, mitigation of cancertreatment side effects Potential to compete with G-CSF ($5+ billion drug from

    Amgen)

    Curaxins: Broad range anti-cancer drugs $50 billion growing market

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    There is no approved drug which caneffectively protect from ARS

    The Threat - Nuclear Attack

    A nuclear event has beenidentified by US Congress asa number one securitythreat

    A terrorist attack with a 10 KT

    device will kill 400,000people in NYC (Institute ofMedicine Report, June 2009)

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    CBLB502 Fits Desirable Countermeasure Profile

    Highly efficacious- Increases survival of primates from 20% to >70%

    Safe- Completed initial human Phase I safety trial

    Easy to use in multiple real-life scenarios

    Single intramuscular injection for self- or hospital administration

    - Effective from 24 hr before to 72 hr after exposure to radiation

    Easy to produce & store- Established high-yield cGMP manufacturing process

    - Stable at room temperature7

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    Recent Milestones CBLB502

    Phase I ascending-dose safety trial successfullyconcluded June 2009

    $32 million in development contracts from DoD andBARDA/HHS and NIAID/NIH received in 2008/2009(~$21 million left + proposals for ~$30 million inadditional funds pending)

    DoD RFP published December 2009 for advanced

    development and procurement of doses

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    CBLB502: Mechanism of Action

    CBLB502 protects from both gastrointestinaland hematopoietic components of radiation

    death

    NF-kBCBLB502 TLR5IAPs, Bcl-2SOD2, ferritinCytokines

    Suppress apoptosisInactivate ROSPromote regeneration

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    CBLB502 mobilizes multiple mechanisms of

    radiation defense, all stemming from TLR5activation

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    A New Principle of Radioprotection

    Published in Science -April 11,2008

    Validates mechanisms of action ofthe drug and protective effect onmice & primates

    First Science publication onradioprotection in more than 30years

    Selected as one of top 10 science advances for researchfunded by NIAID in 2007- 2008

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    TBI, Gy InjectionsN

    total

    N

    survivors

    % survivalP-value vs.

    vehicle6.5 CBLB502, 0.04 mg/kg @+1h-+48h (pooled) 44 30 68.2% 0.002

    6.5 Vehicle (PBS) @+1h, +25h (pooled) 18 4 22.2% -

    Days after 6.5 Gy gamma-TBI0 10 20 30 40

    %o

    fsurviv

    ors

    0

    20

    40

    60

    80

    100

    vehicle (PBS), n=8CBLB502 @ +16h, n=12CBLB502 @ +25h, n=10CBLB502 @ +48h, n=12

    CBLB502 Efficacy: Survival (Mitigation) after LD70 IR

    Effective when injected up to 48 hours after radiation

    Non-human primates

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    CBLB502: Organ and tissue recovery of lethally

    irradiated primates

    Pathology data demonstrates protection of GI tract, blood,immune system and skin

    50% subjects have no observed abnormalities on the day 40

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    Animal Efficacy Rule Path to FDA licensure

    Established FDA pathway to approve drugs whereefficacy is unethical to test in humans

    Dramatically reduces development time and costs

    Compliance with CMC requirements

    Efficacy in two animal species including rhesus

    macaques using survival as endpoint Safety in healthy humans

    Well understood mechanism of action (to provide

    biomarkers of efficacy)

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    Cell Bank

    Test ResidualsQC protocols, stability

    Formulation

    Bioassay

    Manufacturing

    Production Strain, DSP

    Preclinical & ClinicalStudies

    LaboratoryStrain

    FermentationImprovement

    MBF

    CBLB502 ARS: CMC Effort

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    GMP process developedDrug released

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    TBI Dose ParameterTime relative to TBI (if applicable)

    -45' +1h +16h +25h +48h +72h

    LD60-70

    Survival benefit +40% +45% +45% +40%-60% +45% TBD

    Thrombocytopenia reduction +++ +++ +++ +++ +++ +++

    Neutropenia reduction + ++ ++ ++ + +

    Improved BM, spleen, thymus +++ +++ +++ +++ +++ TBD

    Improved GI mucosa ++ +++ Ongoing Ongoing Ongoing TBD

    Cytokine release (G-CSF, IL-6, etc.) +++ +++ +++ +++ +++ TBD

    Data on dose dependence of efficacy TBD Ongoing TBD TBD

    LD10-20

    Thrombocytopenia reduction +++ +++ +++ +++ +++ ++

    Neutropenia reduction + ++ ++ ++ + +Cytokine release (G-CSF, IL-6, etc.) +++ +++ +++ +++ +++ ++

    Data on dose dependence of efficacy Ongoing TBD TBD TBD TBD

    No TBI

    Increased platelet levels +++

    Increased neutrophil levels ++

    Cytokine release (G-CSF, IL-6, etc.) +++

    Data on dose dependence of efficacy

    +++: strong effect; ++: moderate effect; +: minor effect; : data collected

    CBLB502 ARS: Summary of Primate Studies

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    19 studies with over 700primates tested dose-

    dependence for the drug,efficacy time window and effectsof various radiation doses

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    50 human volunteers in groups of 6 receivedascending doses of the drug

    Trial completed; database locked mid-July Dose limiting toxicity (DLT) defined

    Adverse event profile described; predictable and

    related to the known pharmacology of CBLB502

    Predicted safe dose in humans exceedsprotective dose in primates (based onbiomarkers)

    All biomarkers project similar human dose

    Summary of Phase I trial of CBLB502

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    - - Currently concluding second human safety trial- Expect to complete all other remaining requirements

    needed for FDA in 2010/2011

    Manufacturing&

    Clinical/Regulatory

    Formulation

    Non-ClinicalSafety

    Non-ClinicalEfficacy

    Manufacturing of Consistency Lots

    Reprotox Studies inRabbits & Rats-Seg. II

    Phase II Safety TrialPh IIA (100 subjects) & Ph IIB (~500 subjects)

    Development & Stability Studiesof Lyophilized Formulation

    Reprotox Studies inRats-Seg. I&III

    GMP manufacturing(>100,000 doses)

    INDFiled

    Pivotal GLP Mouse& PrimateEfficacy Studies to support NDA filing

    GLP AcuteMouse & Primate

    Toxicology Studies

    Processvalidation

    Dose EscalationTrial - Phase Ia(50 volunteers)

    10/092004 Q410

    Efficacy in Mice,Rats and Primates

    Completed

    Start BLAFiling

    Federal grant support fromDoD and HHS/BARDA

    Stability Studies of the Final Product

    GLP 2-weekMouse & Primate

    Toxicology Studies

    Mechanism of Action;Markers of Efficacy

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    Protectan CBLB502: Development Timeline

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    CBLB502 - ARS Market Potential Back of the Envelope

    DoD - 2 million potential doses for US military BARDA/HHS - 5-20 million potential doses for protection

    of US civilians (Strategic National Stockpile)

    Primary sales targets: Need understood, concepts of usedeveloped, high degree of financial commitment,relations with CBLI in place

    Secondary sales targets: Serious public concern, policies

    being developed

    Projected addressable market ~$500 M/year (w/penetration)No competing products today

    RFP from DoD indicates commitment to procurement

    Israel, UK, Canada, India, China, Japan, S. Korea

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    CBLB502: Protection from Local Irradiation

    Strong mitigation of radiological damage of healthytissues shown in mouse model of head-and-neck

    damage directly supports first medical trial

    3x10 Gy daily with CBLB502 pretreatment

    0 5 10 1560

    70

    80

    90

    100

    110 10 Gy x3 (CBLB502 + 10 Gy) x3

    Days

    Bodywe

    ight,%

    3x10 Gy daily

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    CBLB502: Phase I/II Head & Neck Human Trial

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    Open IND

    Funded by $5.3 million stimulus grantreceived September 2009

    Protocol submitted to IRB

    Planned to start at Roswell Park Cancer

    Institute 2010

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    Protectan CBLB612Stem Cell Inducing Agent

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    CBLB612: Potential Applications

    Recovery from myelosuppression associated withchemotherapy (breast cancer, leukemia, lymphomas, etc.)

    Donor treatment in bone marrow transplantation(improvement or replacement of aphaeresis)

    All other clinical applications of G-CSF (e.g.,myelodysplasticsyndrome)

    Opportunity for combination with or substitute forG-CSF

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    Dramatic improvement of blood recovery duringCyclophosphamide treatment in mice

    CBLB612: Supportive Care During Chemotherapy

    WBC

    0.00

    5.00

    10.00

    15.00

    20.00

    25.00

    30.00

    10x3/ul

    CBLB612 10.33 2.66 3.09 14.73

    PBS 9.65 1.98 0.43 7.21

    day -5 day7 day14 day22

    White Blood Cells

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    CBLB612 is 6x more efficacious than G-CSF andinduces both early and late progenitor cells.

    Effects of CBLB612 and G- CSF are synergistic

    CBLB612 Induces Propagation of HSCs

    CBLB612 orG-CSFCBLB612 orG-CSF

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    CBLB612: Product Development Strategy

    6-month Phase I safety study in healthyvolunteers enables full assessment of

    induction and mobilization of stem cells inperipheral blood, a direct predictor ofefficacy of the drug

    Principle efficacy assessment in Phase I =potential partnering

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    Zhejiang Hisun Pharmaceutical license for Chinasigned Sept. 2009

    ($1.65M upfront development, 10% royalties)

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    Curaxin Product LineAnti-cancer drugs

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    Curaxins: Overview

    First-in-class broad-spectrum anticancer drugs

    Small molecules suitable for oral administration

    Novel mechanism of action simultaneous targetingthree major pathways deregulated in cancer

    Composition of matter patent applications

    Efficacy in multiple animal models of major cancertypes including breast and prostate cancer

    Proof of concept Phase II trial in prostate cancer

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    INCURON JV for Curaxin Development

    50/50 joint venture with BioprocessVentures, Moscow

    ~$18M to reach Phase II for newgeneration of Curaxins

    CBLI to serve as subcontractor to overseemechanistic studies and clinical

    development

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    Financial Summary

    Mcap (at 3/31/10): $96M

    Shares Outstanding: 27M common

    39M fully diluted

    Remaining Govt. Grants & Contracts committed to supportCBLB502 for defense and medical applications (at 12/31/09):$16M

    Pending proposals for additional grants and contracts to support all CBLIprograms: $46M

    CBLI Cash & Rcvbles (at 12/31/09): $4.7M

    Additional $4.5M net proceeds raised in Private Placement

    Avg. Monthly Burn Rate (CBLI cash): $200,000

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    Scientist and serial entrepreneur

    Founder of Dia-M and The Fellowshipfor Interpretation of Genomes (FIG)

    Founder and Former CEO of

    Integrated Genomics, Inc. (97-03)

    Michael Fonstein, PhDChief Executive Officer & President

    SVP of Basic Science, RoswellPark Cancer Institute

    Former Chair, Dept. MolecularBiology at Cleveland Clinic

    30+ issued patents

    150+ research publications

    Andrei Gudkov, PhD, D.SciChief Scientific Officer

    20 years of financial andaccounting experience

    8 years as a corporatecontroller of a public company

    Jack Marhofer, MBA, CMA, CFM

    Chief Financial Officer

    Former Director of BusinessDevelopment at IntegratedGenomics, Inc.

    Expert in technical sales andcontract negotiations

    Yakov Kogan, PhD, MBA

    Chief Operating Officer

    CBLI Management Team

    25 years global oncology drugdevelopment experience

    Senior positions in clinicaloperations at CROs

    Led clinical development inseveral publicly traded biotechcompanies

    Michael Kurman, MD

    Chief Medical Officer

    30 years of Pharma experience

    Former Director of Drug Safetyat TAP Pharmaceuticals, Inc.

    Farrel Fort, PhD, MBA, DABT

    Vice President, Drug Development

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