Wedbush Life Sciences Management Access Conference

August 17, 2011

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 develops drugs against major unmet biodefense and medical needs

Countermeasures against lethal radiation exposure

Supportive care drugs against side effects of radiotherapy and chemotherapy of cancer

Novel anticancer therapeutics

Mission

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CBLI Summary

• September 2010 $45 million DoD contract for development and conditional purchase

• July/November 2010 FDA Fast Track and Orphan Drug Status for CBLB502• June 2011 $23.5 million financing

Recent Significant Events

• Money raised from capital markets $89 million• Federal grants and contracts $97 million• JV-type project specific funding $18 million

Funding History

• Incorporated June 2003 Spin-off from the Cleveland Clinic• NASDAQ listed since 2006 Ticker: CBLI• HQ - Buffalo, NY ~52 full time employees (majority PhDs &MDs)

• Key molecules protected by recently granted US & international patents

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CBLI Drug Candidates

Protectan CBLB502

Protection from lethal radiation exposure - Enters Equivalent of Phase III through FDA animal rule in 2011/2012

Reduction of cancer treatment side effects, and direct anticancer activity – Several trials planned to start 2011/2012

Protectan CBLB612

Reduction of cancer treatment side effects, general hematopoeitic stem cell stimulation - Advanced preclinical studies in 2011

Curaxins CBLC102 and CBLC137

Direct-acting anticancer drugs - Phase I/II studies and ongoing formal preclinical

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Underlying Science and Origin of CBLI Drugs

• Understanding of the role of apoptosis (regulated cell death) in multiple human diseases

• Bacterial signaling factors as drug candidates suppressing apoptosis

• New class of DNA-intercalators with direct anticancer activity

• Hematopoietic stem cell induction for supportive care in cancer treatment

• Inhibitors of multi-drug transporters, universal carcinogens and other established cancer target proteins

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Unique drug lead & technology portfolio

Paradigm-shifting innovative drug development and treatment concepts developed by CBLI’s founder Prof. Andrei Gudkov

Advanced leads of Protectan and Curaxin classes

Accelerated drug development path

Radiation biodefense countermeasures

• FDA animal efficacy rule

• Advanced stage of development

Oncology market

• Alliance with leading clinical partners

Strategic Advantages

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CBLB502Defense

Lethal Radiation Exposure

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Leading Biodefense Drug CBLB502Landscape

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Increasingly high risk of nuclear disaster

Terrorist attack• 10KT nuclear device estimated to cause up to 400,000 casualties if exploded

in Manhattan

Nuclear stations• Fukushima: nuclear industry forced to recognize a need for drugs dealing

with consequences of nuclear accidents

Lack of approved countermeasures

Growing pressure on governments

Need for CBLB502 today is higher than yesterdayCBLB502 uniquely positioned to become a critical element in defense

against such accidents

Leading Biodefense Drug CBLB502Competitive Advantages

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CBLB502 remains strongest radiation countermeasure

• Growing information on outstanding efficacy of CBLB502 in primates

• Lack of reports on comparably powerful drugs

Furthest advancement along the “Animal Rule” path (multiple human trials, animal efficacy studies with >900 primates)

Established large-scale GMP production process

Outstanding stability

Accelerated FDA process – Fast Track, Orphan Drug

Significant funding by government agencies

Rapid development process facilitated by top quality regulatory team

Clear shortlist of remaining steps

CBLB502 as Medical Radiation Countermeasure Origin & Mechanism of Action

• Derivative of a protein of bacterial origin (flagellin) modified to reduce immunogenicity and toxicity and improve production

• Acts through mobilization of multiple mechanisms all mediated by activation of pro-survival NF-kB signaling pathway

• CBLB502 selectively protects normal tissues (but not malignant tumors) from radiation

• Increases survival of stem cells and early progenitors of hematopoietic system and stimulated regeneration of different HP lineages

• Reduces radiation damage to and stimulate regeneration of crypts, villi and lamina propria of GI tract

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Development of CBLB502 towards Approval as Countermeasure via FDA’s Animal Rule

• Efficacy in animal models that mimic human disease

• Human safety

• Well understood mechanism of action to justify selection of objective indicators (biomarkers) in humans

Drug candidates, efficacy of which cannot be directly tested in humans due to ethical reasons, are developed according to Animal Rule:

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CBLB502 is efficacious in mice and monkeys in protecting and mitigating regimens

27 studies with non-human primates; >180 studies (with multiple strains of mice, types of irradiation,

survival, HP, GI and other endpoints)

NIH Swiss mice, 13 Gy of total body irradiation

time after irradiation, days

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

ani

mal

sur

viva

l, %

0

20

40

60

80

100 CBLB502 (n=50)

amifostin (n=13*)

saline (n=25)5-AED (n=5)

Mice

0

10

20

30

40

50

60

70

80

90

100

0 5 10 15 20 25

Days after TBI

Su

rviv

al

(%),

n=

40

7.5 Gy, + 16h, PBS/Tween80

8 Gy, + 16h, PBS/Tween80

7.5 Gy, + 16h, CBLB502 40 µg/kg

8 Gy, + 16h, CBLB502 40 µg/kg =25%

=37%=37%

protection mitigation

Days after 6.5 Gy gamma-TBI0 10 20 30 40

% o

f su

rviv

ors

0

20

40

60

80

100

vehicle (PBS), n=8

CBLB502 @ +16h, n=12

CBLB502 @ +25h, n=10

CBLB502 @ +48h, n=12

Survival of rhesus monkeys after 6.5 Gy -TBI

Days after irradiation

0 10 20 30 40

% o

f s

urv

ivo

rs

0

20

40

60

80

100

120

Vehicle (N=8) at -45'

CBLB502, 0.04 mg/kg (N=11) at -45'

protection mitigationNHPs

Days after 6.5 Gy gamma-TBI0 10 20 30 40

% o

f su

rviv

ors

0

20

40

60

80

100

vehicle (PBS), n=8

CBLB502 @ +16h, n=12

CBLB502 @ +25h, n=10

CBLB502 @ +48h, n=12

Survival of rhesus monkeys after 6.5 Gy -TBI

Days after irradiation

0 10 20 30 40

% o

f s

urv

ivo

rs

0

20

40

60

80

100

120

Vehicle (N=8) at -45'

CBLB502, 0.04 mg/kg (N=11) at -45'

protection mitigationNHPs

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Summary of CBLB502 Efficacy Features in NHPs

• Species: rhesus monkey, Macaca mulatta (best-studied primate model in ARS); both sexes, young adults

• Doses of radiation tested: from LD10/40 to LD75/40 TBI in survival studies and LD90-100 TBI in GI morphology studies

• Efficacious times of treatment: at least from -45’ to >48 hours (treatment at 120 hours is not efficacious)

• Efficacious doses of CBLB502: >=10 ug/kg is efficacious at all time points and radiation doses tested, 3 ug/kg was determined as EC50

CBLB502 treatment increases survival (by up to 3 times); reduces severity and duration of thrombocytopenia;

reduces severity of neutropenia; reduces morphological damage in BM, GI tract, spleen, thymus and lymph nodes

27 studies with total of 905 non-human primates

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Summary of CBLB502 Efficacy Features in Mice

CBLB502 treatment increases survival and reduces morphological damage in BM and GI tract

>180 studies (with multiple strains of mice, different ages, types of irradiation, survival, HP, GI and other endpoints)

• Species: house mouse, Mus musculus (best-studied mammalian model in radiation-related studies); both sexes, young adults, multiple strains (ICR, NIH-Swiss, Balb/c, CD2F1, etc.)

• Doses of radiation tested: from LD20/30 to >LD95-100/30 TBI

• Efficacious times of treatment: efficacy from -24 to +25 hrs relative to TBI

• Efficacious doses of CBLB502: >~20 ug/kg is efficacious at all time points and radiation doses tested, ~10 ug/kg was determined as EC50

CBLB502 vehicle16

Mitigating efficacy of CBLB502 against GI manifestation of acute radiation syndrome in primates (Rhesus macaques) that received

extremely high radiation doses

Small intestine, day 7 after 11 Gy TBI

Completed Steps in Production of CBLB502

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• Full industrial-scale process of API production based on recombinant DNA technology

• Single fermentation generating hundreds of thousands of doses

• Reproducibility demonstrated in multiple GMP runs

• Stable as a frozen liquid and in lyophilized form

• Release assays validated

CBLB502 Human Trial Program Summary

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• Total of 150 human volunteers received a range of doses of CBLB502 through 2 studies

• Dose limiting toxicity (DLT) defined (manifested as a flu-like syndrome)

• Calculated efficacious dose in humans is below DLT

• Adverse event profile is predictable and directly related to the mechanism of action of CBLB502

• Methodology established to determine projected human efficacious dose (based on biomarkers)

• All biomarkers project similar human dose

• Collected information enables to start of definitive safety/dose validation trial in healthy volunteers for CBLB502 defense

CBLB502-Biodefense on Path to ApprovalRemaining Tasks

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Completed Remaining steps

CMC

GMP process developed and tested, drug suitable for clinical trials released

Additional consistency runs

Efficacy

Data from ~1,000 primates demonstrates dramatic survival benefits and accelerated

recoveryPivotal animal studies

Human safety

Two trials: 50-subject dose-escalation and 100-subject study completed

Definitive safety study

FDA process

Open IND, Fast Track Status, Orphan Drug Status

Coordinating study protocols, BLA submission

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Summary: CBLB502 as Medical Countermeasure (MRC) against ARS

Highly efficacious as a single doseIncreases survival of irradiated primates from 20 to >70%

Significantly reduces incapacitation of survivors

Protects/treats both GI and HP components of acute radiation syndrome

Broad application time windowFrom prior (24 hr) to & post (>48 hr) exposure to IR

Ease of use

Single intramuscular injection suitable for self- or hospital administration

Stable

Established high-yield cGMP manufacturing process

Safety profile defined

Completed two Phase I safety trials in total of 150 healthy volunteers

Defining human dose

Mechanism of action is well understood

Biomarkers selected and justified

CBLB502 Federal Contract Funding

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GRANT/CONTRACT TITLE AMOUNT DATES

DoD /DTRA, Med. Chem. & Biol.

Defense Res. Program

Radioprotective Mechanisms of

CBLB502$1,300,000 3/07-3/10

DoD/CBMS-JPEO

Chemical Biological Medical

Systems Joint Project Mgt.

BAA-07-01- Advanced

Development of a Medical

Radiation Countermeasure

$10,340,000 3/08-10/09

NIAID (NIH)

BioShield Program

CBLB502 mitigation of radiation

induced thrombocytopenia$1,230,000 9/08-3/10

BARDA (HHS)

BioShield Program

BAA-08-08 -Development of

CBLB502 of mitigation of HP

syndrome

$15,800,000 9/08-10/10

NIH/NIAID

Grand Opportunities (GO) GrantProtectan CBLB502 $5,300,000 9/09-9/11

DoD/CBMS-JPEO

Chemical Biological Medical

Systems Joint Project Mgt.

RFP W9113M-09-R-0010

Advanced Development of a

Medical Radiation

Countermeasure

$45,000,000

(15,000,000 +

30,000,000)

9/10-9/13

DoD /DTRA, Med. Chem. & Biol.

Defense Res. Program

Radioprotective Mechanisms of

CBLB502$1,589,106 1/11-4/12

DoD/CBMS-JPEO

Chemical Biological Medical

Systems Joint Project Mgt.

RFP W9113M-09-R-0010

Advanced Development of a

Medical Radiation

Countermeasure

$1,343,759 6/11-9/13

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Major Funding Opportunity for CBLB502-DefenseBARDA

History of partnership:• September 2008: BARDA awarded CBLI a contract "Therapies for Hematopoietic Syndrome, Bone

Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation" covering:

Performing selected preclinical experiments with non-human primates

Performing stability studies of the GMP-grade CBLB502

Conducting 50-subject healthy volunteer trial

Planning, initiating and overseeing 100-subjects dose validation trial on healthy volunteers and drafting and finalizing the clinical report and submitting such reports to the BARDA and the FDA

Starting total contract value was $13.3M

• September 2009: BARDA increased the total contract value adding $2.3 million, the maximum allowed for non-competitive increase

• CBLI successfully completed all tasks related to this contract by February 15, 2011, 6 months ahead of schedule

• Since 2010, CBLI and BARDA have been negotiating a new contract to fund the remaining steps of the developmental program

• May 2011: BARDA requested coordination of development program with FDA

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Major Funding Opportunity for CBLB502-DefenseBARDA

Path to Contract:

• Meet with FDA to receive input on development path

• Update BARDA proposal and resubmit

• BARDA review and award determination

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Market Potential “Back of the Envelope”

• First “Buying” RFP by DoD ($30 million) for up to 37,500 doses awarded to CBLI, BARDA RFP anticipated

• Hundreds of thousands to millions of doses needed to mitigate the nuclear threat in USA, hundreds of millions of dollars allocated for initial purchase among US agencies

Primary sales targets: DoD, BARDA/HHS, Israel

Secondary sales targets: UK, Canada, India, China, Japan, S. Korea, France

Projected addressable market ~$500 M/year (w/penetration over time)

No competing products today

• Some initial contacts with CBLI

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CBLB502Medical Applications

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CBLB502 as Radiation Therapy Adjuvant (total body irradiation)

• Rescues animals from radiation (allows escalation of radiation dose in cancer treatment)

• Does NOT protect tumor

• Hints towards direct anticancer activity

Survival

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CBLB502 in Preclinical Model of Local Irradiation

Toll-like Receptor 5 Agonist Protects Mice from Dermatitis and Oral Mucositis Caused by Local Radiation: Implications for Head

and Neck Cancer Radiotherapy.

(Int. J. Rad. Onc. Biol. Phys., in press)

Goal:

• Justification of use of CBLB502 as a supporting care radioprotection adjuvant

Results:

• CBLB502 is efficacious against radiation-induced mucositis and dermatitis

Significance:

• Strong preclinical support of use of CBLB502 as radiotherapy adjuvant

• Justification of new application (protection from radiation-induced dermatitis)

Approval of “CBLB502 as supportive care” trial protocol in head and neck cancer patients by Scientific Review Committee of Roswell Park

Head and neck irradiation model in mice

Extending Indications of CBLB502Mitigation of chemotherapy side effects and direct anticancer action

Irinotecan and CBLB502 against Wart colon tumors in Fisher rats

CBLB502 displays both supportive care and direct antitumor activities in rat model of colon cancer

0 4 8 12 16 20 24 28 32Me

an

Tu

mo

r W

eig

ht

(mg

)

200

500

2000

5000

100

1000

10000

Antitumor activity and toxicity of Irinotecan ± CBLB502

in rats bearingadvanced Ward colorectal carcinoma

Time (Days)

0 4 8 12 16 20 24 28 32

Me

an

Bo

dy

We

igh

t (%

)

80

85

90

95

100

105

110

Control

CBLB502 0.2 mg/kg x 5

Irinotecan 200 mg/kg x 3

CBLB502 0.2 mg/kg(5) + Irinotecan 200 mg/kg

CBLB502 0.2 mg/kg(3) + Irinotecan 200 mg/kg

Irinotecan 200 mg/kg + CBLB502 0.2 mg/kg

"Toxicity"

"Antitumor Activity"

Irinotecan daily x3, 200 mg/kg i.v. +/- CBLB502

0 4 8 12 16 20 24 28 32 36 40 44 48 52Me

an

Tu

mo

r W

eig

ht

(mg

)

200

500

2000

5000

100

1000

10000

Indivadual rat bearing advanced Ward colorectal carcinoma

response to CBLB502 0.2 mg/kg/day by i.p. daily x 5

Time (Days)

0 4 8 12 16 20 24 28 32 36 40 44 48 52

Me

an

Bo

dy

We

igh

t (%

)

90

95

100

105

110

115

Rat # 1

Rat # 2

Rat # 3

Rat # 4

"Toxicity"

"Antitumor Activity"

0

CBLB502, x3 daily, 0.2 mg/kg

Irinitecan+CBLB502

placebo

Irinitecan alone

(all dead from GI toxicity)

CBLB502 rescues animals from Irinotecan toxicity with no

interference with its antitumor activity

CBLB502 caused complete regression of tumors in part

of the animals

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Direct Anti-tumor Effects of CBLB502

healthy

TLR5- tumors in liver

TLR5+ tumors in liver

TLR5+ tumors

TLR5- tumors

CB

LB5

02

No toxicity

Tumor suppression

Tumor suppression

Tumor suppression

No antitumor effect

TLR5-negative tumors

TLR5-positive tumors

livermetastase

liver

metastase

Control (vehicle) CBLB502, 5hrs post injection

• Identification of target tissues enables rational choice of indications and regimens

• “CBLB502 as a single agent” trial protocol was approved by Scientific Review Committee of Roswell Park

Many of these trials enable assessment of both supportive care and direct anti-tumor activity of CBLB502

Prospective Clinical Trials of CBLB502 in Cancer Patients

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• Reducing severity of mucositis and enhancing efficacy of radiotherapy of H&N

cancer

• Reducing severity of bowel toxicity and enhancing efficacy of radiotherapy of

pancreatic cancer

• Reducing severity of diarrhea in colon cancer patients treated with Irinotecan

• Treating primary hepatocellular carcinoma (liver cancer)

• Treating liver metastasis of colon cancer

• Treating liver metastasis of breast cancer

• Pre-operational treatment of prostate cancer

CBLB502 Clinical Trials

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• “CBLB502 as a single agent” trial approved by Scientific Review Committee of Roswell Park

• “CBLB502 as supportive care” trial in head and neck cancer patients approved by Scientific Review Committee of Roswell Park

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CBLB612Stem Cell Inducing Agent

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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-CSF

CBLB612 or

G-CSF

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Dramatic improvement of blood recovery during Cyclophosphamide treatment in mice

CBLB612 Supportive Care During Chemotherapy

WBC

0.00

5.00

10.00

15.00

20.00

25.00

30.00

10x3/u

l

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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Principle efficacy assessment in Phase I = potential partnering

CBLB612 Product Development Strategy

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

• 2.5 years from today to critical human data

• Hisun licensing deal of 2009 provides additional data and possibility of synergistic development

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CuraxinsAnticancer drugs

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Curaxins

Synthetic small molecules with proprietary structure

Unique mechanism of action: simultaneously affect multiple molecular targets in cancer cell

Efficacious in a broad spectrum of preclinical tumor models

Mechanism of action enables additional clinical indications beyond cancer treatment (anti-inflammatory, anti-infective)

First generation Curaxin CBLC102 is in clinical trial in patients with liver metastases

New generation Curaxin CBLC137 is at advanced stage of preclinical development

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Incuron – JV for Curaxin Development

50/50 joint venture with Bioprocess Ventures, Moscow

~$18M to reach Phase II for new generation of Curaxins in US and Russia and conduct human trials in liver cancer in Russia for CBLC102

CBLI oversees mechanistic studies and formal development

Phase Ib trial for CBLC102 started October 2010 in Russia

Phase I trial with oral formulation of next generation Curaxin CBLC137 in solid tumors planned for 1Q12 in Russia

Optimization of IV formulation of next generation Curaxin CBLC137 for future trial in US ongoing

Demonstrates feasibility of model combining advantages of US and Russian development platforms

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Milestones

• Start of pivotal animal efficacy studies for CBLB502 defense

• Start of definitive safety/dose validation trial in healthy volunteers for CBLB502 defense

• CBLB502 trial in advanced liver metastases patients for safety/antitumor effect

• CBLB502 trial in head and neck cancer patients for supportive care indication

• Completion of CBLC102 trial in liver cancer patients in Russia

• Phase I trial with oral formulation of next generation Curaxin CBLC137 in Russia

• Top level peer reviewed publications

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Financial Summary

• Shares Outstanding: 35M common, 52M fully diluted

• Government Grants & Contracts support CBLB502 for defense and limited medical applications: $14.8M unspent as of 6/30/11 (excl. $30M option for first purchase)

• CBLI subsidiary Incuron funds Curaxin development for next 2-3 years: $12.1M left

• CBLI Cash & Receivables (at 6/30/11): $29.5M (CBLI only), $2.3M (Incuron – first tranch)

• Avg. Monthly Burn Rate (on CBLI cash): ~ $1-1.4M (CBLI only)

• 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, PhD

Chief Executive Officer & President

• SVP of Basic Science, Roswell Park Cancer Institute

• Former Chair, Dept. Molecular Biology at Cleveland Clinic

• 30+ issued patents

• 150+ research publications

Andrei Gudkov, PhD, D.Sci

Chief Scientific Officer

• 20 years of financial and accounting experience

• 8 years as a corporate controller of a public company

Jack Marhofer, MBA, CMA, CFM

Chief Financial Officer

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

• Expert in technical sales and contract negotiations

Yakov Kogan, PhD, MBA

Chief Operating Officer

Senior Management Team

• 25 years global oncology drug development experience

• Senior positions in clinical operations at CROs

• Led clinical development in several publicly traded biotech companies

Michael Kurman, MD

Chief Medical Officer

• Over 20 years of regulatory experience at large and small pharma

• Multiple successful NDAs, MAAs, sNDAs, advisory committees

Ann Hards, PhD

Executive Vice President, Regulatory Affairs and Quality Assurance

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Scientific Advisory Board

George R. Stark, PhDChairman 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 Directors

Independent Directors

Bernard L. Kasten, MDFormer CEO, SIGA Technologies

David Hohn, MDFormer President of Roswell Park Cancer Institute

James Antal, CPA, MBAFormer CFO and CIO of Experian

Paul DiCorleto, PhDChairman, Lerner Research Institute

Management

Michael Fonstein, PhDCEO & President, Cleveland BioLabs, Inc.

Andrei Gudkov, PhD, DSciCSO, Cleveland BioLabs, Inc

Yakov Kogan, PhD, MBACOO, Cleveland BioLabs, Inc

Boards

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