Maxim Group Growth Conference September 29, 2009

This presentation includes forward-looking statements and predictions, including statements about potential revenue-bearing transactions, the market potential of CBLI’s technologies and product candidates, and the potential value of pipeline

products. These statements represent the Company’s 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 Company’s pipeline may not succeed or that commercial

transactions may not go forward as planned.

Safe-Harbor

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CBLI is developing two families of drugs:

Protectans: protect healthy tissues fromradiation damage

Curaxins: kill tumor cells

Mission

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CBLI Target Product Market Opportunities

• CBLB502: Protection from Acute Radiation Syndrome (ARS) (accelerated pathway to licensure)

– $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 cancer treatment side effects

– Potential to compete with G-CSF ($5+ billion drug from Amgen) or other hematopoietic growth factors

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

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CBLI Summary

IP

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

Partnerships

• Money raised from capital market $51 million• Federal grants and contracts >$50 million

Funding History

• Incorporated in June 2003 Spin-off from the Cleveland Clinic• HQ - Buffalo, NY 32 employees (majority PhDs & MDs)

• ~20 patent applications filed• First CBLB502 US patent granted

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Protectan CBLB502ARS and cancer treatment side effects

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There is no approved drug which can effectively protect from radiation injury

The Threat - Nuclear Attack

• A nuclear or radiological event has been identified by US Congress as a number one security threat

• A terrorist attack with a 10 KT device will kill 400,000 people in NYC (Institute of Medicine Report, June 2009)

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Recent Milestones – CBLB502

• Phase I ascending-dose safety trial successfully concluded June 2009

• Department of Defense Sources Sought Notice for Nuclear Medical Countermeasures - May 2009

• $23 million in development contracts from DoD and BARDA/HHS and NIAID/NIH received in 2008 (~$13 million left)

• Comparable levels of new funding applied for 2009-2010 (~$8 million received September 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 temperature

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A New Principle of RadioprotectionDiscovery of unique radio-protectant Protectan CBLB502 published in Science magazine received attention from the world scientific community

• Published on April 11,2008

• Validates mechanisms of action of the drug and protective effect on mice & primates

• First publication on radioprotection in more than 30 years

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

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CBLB502: Mechanism of Action

CBLB502 protects from both gastrointestinal and 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 TLR5

activation

TBI, Gy Injections N total

N survivors % survival P‐value vs. 

vehicle

6.5 CBLB502, 0.04 mg/kg @+1h‐+48h (pooled) 44 30 68.2% 0.0026.5 Vehicle (PBS) @+1h, +25h  (pooled) 18 4 22.2% ‐

Days after 6.5 Gy gamma-TBI0 10 20 30 40

% o

f sur

vivo

rs

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 where efficacy is unethical to test in humans

Dramatically reduces development time and costs

• Compliance with standard CMC requirements

• Efficacy in two animal species (e.g. mice and 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

ManufacturingProduction Strain, DSP

Preclinical & ClinicalStudies

Laboratory Strain

FermentationImprovement

MBF

CBLB502 – ARS: CMC Effort

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Time relative to TBI (if applicable)TBI Dose Parameter

‐45' +1h +16h +25h +48h +72hSurvival benefit +40% +45% +45% +40%‐60% +45% TBDThrombocytopenia reduction +++ +++ +++ +++ +++ +++

Neutropenia reduction + ++ ++ ++ + +

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

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

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

LD60‐70

Data on dose dependence of efficacy √ √ TBD Ongoing TBD TBD

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

Neutropenia reduction + ++ ++ ++ + +

Cytokine release (G‐CSF, IL‐6, etc.) +++ +++ +++ +++ +++ ++LD10‐20

Data on dose dependence of efficacy Ongoing √ TBD TBD TBD TBD

Increased platelet levels +++

Increased neutrophil levels ++

Cytokine release (G‐CSF, IL‐6, etc.) +++No TBI

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 700 primatestested dose-dependence for the drug, efficacy time window and

effects of various radiation doses

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• 50 human volunteers in groups of 6 received ascending 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 exceeds protective dose in primates (based on biomarkers)

• All biomarkers project similar human dose

Summary of Phase I trial of CBLB502

CBLB502 - ARS: Developmental Status

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COMPLETED (2006-2009)• Multiple meetings with FDA laying out the development path

• Animal efficacy for multiple regimens, radiation doses and time points

• Phase IA trial to determine MTD in humans

• Establish and characterize efficacy biomarkers in humans

PENDING (2009-2010)• FDA meeting finalizing protocols for Phase IB and pivotal NHP studies (4Q

2009)

• Phase IB (4Q 2009 – late summer 2010)

• Pivotal NHP study (2009 – early 2010)

• Manufacturing consistency runs and extended product stability (2009-2010)

• FDA submission (late 2010)18

CBLB502 - ARS Market Potential “Back of the Envelope”

• 1‐2 million doses for US army

• 5‐20 million doses for protection of US civilians  

Initial sales targets: Need understood, concepts of use developed,  high degree of financial commitment, relations with CBLI in place 

Secondary sales targets : Serious public concern, policies being developed 

Projected addressable market ~$500 M/yearNo competing products today

May 2009 RFI from DoD indicates official start of new procurement cycle

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

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Total Body Irradiation • Acute leukemia - reduction of lethality and improved recovery of patients

from allogenic bone marrow transplantation

Local Irradiation• Head and neck cancer - reduced radiotherapy side effects (mucositis of

mouth, throat and esophagus, larynx and dental caries)

• Prostate cancer - protection of GI (rectal bleeding, diarrhea, bladder damage)

• Lung cancer - protection of healthy lung tissue from inflammation

Chemotherapy• Multiple drugs and cancers - reduction of dose limiting adverse effects

of chemotherapeutic drugs (myelosuppression, GI toxicity, nephrotoxicity, etc.)

CBLB502 - Medical ApplicationsReducing Cancer Treatment Side Effects

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CBLB502 as Radiation Therapy Adjuvant (protection from total body irradiation)

• Rescues animals from radiation toxicity

• Potentiates effect of radiotherapy

• Allows radiation dose escalation

• Does NOT protect tumor

Survival

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CBLB502: Protection from Local Irradiation

Strong mitigation of radiological damage of healthy tissues 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

Bod

y w

eigh

t, %

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 grant received September 2009

• Protocol submitted to IACUC

• Planned to start at Roswell Park Cancer Institute 2009/2010

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Protectan CBLB612Stem Cell Inducing Agent

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CBLB612: Potential Applications

• Recovery from myelosuppression associated with chemotherapy (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 for G-CSF

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Dramatic improvement of blood recovery during Cyclophosphamide treatment in mice

CBLB612: Supportive Care During ChemotherapyWBC

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 and induces both early and late progenitor cells.

Effects of CBLB612 and G- CSF are synergistic

CBLB612 Induces Propagation of HSCs

CBLB612 or G-CSFCBLB612 or G-CSF

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CBLB612: Product Development Strategy

6-month Phase I safety study in healthy volunteers enables full assessment of induction and mobilization of stem cells in peripheral blood, a direct predictor of efficacy of the drug

Principle efficacy assessment in Phase I = potential partnering

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Zhejiang Hisun Pharmaceutical license for China signed 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 targeting three major pathways deregulated in cancer

• Composition of matter patent applications

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

• Proof of concept Phase II trial in prostate cancer

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Broad Spectrum in vivo Efficacy

Comparable efficacy in:- hormone refractory prostate cancer- advanced breast carcinoma- renal cell carcinoma

HCT116 sc xenograft model

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

days of treatment

Tum

or v

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m3)

MCCBL0137

DLD1 tumors

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101214161820

1 2 3 4 5 6 7 8 9 10 12 13 14

days of treatment

incr

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in tu

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vol

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MC

CBL0137

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Complete cure of mouse fibrosarcomas treated by combination of Curaxin and HSP90 inhibitor (DMAG).

Same effect is shown in B16 melanoma model.

Synergistic Effects with Heat Shock Inhibitors

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INOCURON – JV for Curaxin Development

• 50/50 joint venture with Bioprocess Ventures, Moscow

• >$15M to reach Phase II for new generation of Curaxins

• Term sheet signed

• Definitive documents expected to be signed in September/October

• Scientist and serial entrepreneur

• Founder of Dia-M and The Fellowship for Interpretation of Genomes (FIG)

• Founder and Former CEO of Integrated Genomics, Inc. (‘97-03)

Michael Fonstein, PhDChief Executive Officer & President

• SVP of Basic Science, Roswell Park Cancer Institute

• 30+ issued patents

•150+ research publications

Andrei Gudkov, PhD, D.SciChief Scientific Officer

• 20 years of financial and accounting experience

• 8 years as a corporate controller of a public company

Jack Marhofer, MBA, CMA, CFMChief Financial Officer

• Former Director of Business Development at Integrated Genomics, Inc.

• Expert in technical sales and contract negotiations

Yakov Kogan, PhD, MBAChief Operating Officer

CBLI Management Team

• 25 years of global oncology drug development experience

• Senior positions in clinical operations at CROs

• Led clinical development in several publicly traded biotech companies

Michael Kurman, MDChief Medical Officer

• 30 years of Pharma experience

• Former Director of Drug Safety at TAP Pharmaceuticals, Inc.

Farrel Fort, PhD, MBA, DABTVice President, Drug Development

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Scientific Advisory BoardGeorge R. Stark, PhD

Chairman of SAB, Member of NAS, Former director of LRI, Scientific Advisor to Amersham and Genentech, pioneered numerous major research technologies

Inder Verma, PhDMember of NAS, Professor of Salk Institute, Founder and Scientific Advisor to Cell Genesys, Signal Pharmaceuticals, UroGenesys, Ventana Pharmaceuticals, Quark Biotech. Internationally recognized leader in cancer biology and inflammation

Bruce Blazar, MDProfessor, Chair in Transplantation Immunology of University of Minnesota. Member of the FDA Advisory Committee, SAB member of BioMarin Pharmaceutical, Seattle Genetics, etc.

Board of DirectorsIndependent Directors

Bernard L. Kasten, MDFormer CEO, SIGA Technologies

Daniel Perez, MDFormer CEO & President of Berlex Biosciences, a Division of Bayer AG

James Antal, CPA, MBAFormer CFO and CIO of Experian

Paul DiCorleto, PhDChairman, Lerner Research Institute

ManagementMichael Fonstein, PhD

CEO & President, Cleveland BioLabs, Inc.

Andrei Gudkov, PhD, DSciCSO, Cleveland BioLabs, Inc

Yakov Kogan, PhD, MBACOO, Cleveland BioLabs, Inc

CBLI Boards

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Maxim Group Growth Conference September 29, 2009