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Investor Presentation NASDAQ:CBLI

May 29,2012

Copyright 2012 © Cleveland BioLabs, Inc. All rights reserved.


Safe Harbor

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 CBLI’s judgment as of the date of this

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

results 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.

The factors that could cause actual results to differ are discussed in more detail in

CBLI’s filings with the Securities and Exchange Commission, including its latest

Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Reports on Form 8-K. These reports are available under the “Investors” tab on

CBLI’s website at www.cbiolabs.com.

2


Investment Highlights

• Broad pipeline with novel oncology and orphan products developed by CBLI

and majority-owned subsidiaries (Incuron, LLC and Panacela Labs, Inc.)

• Dual application for lead product as radiation countermeasure

• Opportunity for accelerated commercialization through biodefense

• Open INDs for oncology trials

• Leveraging founders’ knowledge and connections in Russian Federation to

expedite clinical data and fund subsidiaries

• Strategic alliances with Cleveland Clinic, Roswell Park Cancer Institute and

Children’s Cancer Institute of Australia

• Track record of non-dilutive grants and contracts ($85M, including $30M

conditional purchase for radiation countermeasure)

• Strong IP portfolio with over 20 patent applications worldwide, including

composition of matter (grated patents in USA, Europe, Asia)

3


CBLI Corporate Structure

4


Understanding tumor mechanisms leads to new approaches to

cancer treatment and normal tissue protection

5

Founding Technology Concepts

organism

Apoptosis

TumorNormal tissues

radiation

Imitating tumor antiapoptoticmechanisms: inhibition of p53

(Pifithrins) and activation of NF-kB (Protectans)

• Komarov et al., 1999. Science 285, 1733 • Burdelya et al., 2008. Science 320: 226

Necrosis, senescence, mitotic catastrophe

p53

NF-kB

bone marrow

lymphoid organs

small intestine

hair follicles

Restoring apoptosis in tumor cells by simultaneous activation of p53 and

inhibition of NF-kB (Curaxins)

• Gasparian et al., 2011. ScienceTransl Med 3(95): 95ra74


Product Pipeline – CBLI Corporate

6

Product Research Pre-Clinical Ph I Pivotal BLA

Protectan CBLB502

Radiation

Countermeasure

Product Research Pre- Clinical Ph I Ph II Ph III

Protectan CBLB502

Advanced Solid Tumors (companion diagnostic)

Protectan CBLB612

Bone Marrow Transplant (stem cell transplantation)


Product Pipeline – Incuron, LLC

7


Curaxin CBL0102

Advanced Solid Tumors (non-proprietary)

Curaxin CBL0137

Advanced Solid Tumors (proprietary)


Product Pipeline – Panacela Labs, Inc.

8


Revercom

Chemo Adjuvant

Mobilan

Targeted Cancer

Therapy

Arkil

Androgen Receptor

Inhibitor

Antimycon

Cancer Therapeutic

Xenomycins

Anti-infectives


Protectan CBLB502 Radiation Countermeasure

Targeted Cancer Therapy

Supportive Care

9


CBLB502 uniquely positioned as therapeutic against ARS

10

Radiation Countermeasure Opportunity

• Nuclear attack identified by US and global leaders as number one security

threat as evidenced by Reauthorization of Pandemic All Hazards Preparedness Act

• Fukushima disaster highlights risk of nuclear industry

• Drug Profile:

• 1 intramuscular injection

• Up to 48 hrs. post exposure

• Ideal for stockpile & distribution

• There are no FDA licensed countermeasures for Acute Radiation Syndrome (ARS)


CBLB502 as Medical Radiation Countermeasure

Origin & Mechanism of Action

• Protein of bacterial origin (flagellin) pharmacologically optimized to improve stability,

decrease immunogenicity and improve production yield

• Acts through multiple mechanisms mediated by activation of pro-survival NF-kB

signaling pathway via highly specific interaction with innate immunity receptor TLR5

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

induced injury

• Increases survival of stem cells and early progenitors of hematopoietic system and

stimulated regeneration of different HP lineages

• Reduces radiation damage to and stimulates regeneration of crypts, villi and lamina

propria of GI tract

11


FDA pathway to approve drugs where efficacy is unethical to test

in humans

12

Unique Regulatory Process – FDA’s Animal Rule

• Efficacy in animal models that mimic human disease, with relevant

end-points

• Human safety in healthy volunteers

• Well understood mechanism of action to justify selection of objective

biomarkers of efficacy

• Well understood correlation of biomarker response between animal

models and human volunteers to calculate dose conversion

• Fast Track and Orphan Drug Status granted

• Robust manufacturing process with 100,000s of dose equivalents on

hand


CBLB502 Efficacy

• N= >900 non-human primates (“NHP”s) over ~ 30 studies

• Multiple strains of mice over ~ 180 studies

• Improved survival (~20% to ~80%)

• CBLB502 reduced damage to HP and GI systems, spleen, thymus and lymph

nodes = increased survival and improved quality of life

13

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

3X improvement in survival,

with CBLB502 survivors having

better quality of life

Mitigation


Projected efficacious dose in humans appears safe

14

CBLB502 Safety in Humans

• Efficacy 150 healthy volunteers received 2-50 µg in 2 studies

• Short-lasting “flu-like” syndrome was primarily observed adverse event - directly related to mechanisms of action resulting in “benign” cytokine upregulation (i.e. no cytokine storm)

• Biomarker data projects human efficacious dose to be below dose limiting toxicity


CBLB502 Countermeasure Path to Licensure

15

Completed Remaining steps

CMC

GMP process developed and tested, drug

suitable for clinical trials released,

100,000s dose equivalents on hand

Additional consistency runs

(to be done after BLA submission, in

parallel with FDA review)

Efficacy

Data from ~1,000 primates demonstrates

dramatic survival benefits and

accelerated recovery

Pivotal 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

Package preparation and

BLA submission


Protectan CBLB502 Oncology Applications

16


CBLB502 is active against TLR5+ tumors and against TLR5+/-

liver metastases

17

CBLB502 Targeted Therapy (summary)

healthy

TLR5- tumors in liver

TLR5+ tumors in liver

TLR5+ tumors

No toxicity

Tumor suppression

Tumor suppression

Tumor suppression

No antitumor effect

TLR5 negative tumors

TLR5 positive tumors

TLR5- tumors


CBLB502 as a single agent can cause complete tumor regression

of Wart colon tumors in Fisher rats

18

TLR5+ Tumor Efficacy of 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

200

500

2000

5000

1000

10000

Me

an

Tu

mo

r W

eig

ht

(mg

)

Time (Days) CBLB502 3xdaily 0.2 mg/kg

* * *

* unpublished data

Copyright 2012 © Cleveland BioLabs, Inc. All rights reserved. 19

CBLB502 Against Liver Metastases of Colon

Cancer *

Intact

Anti-Fas

CBLB502 + anti-Fas

0 5 10 15 20 25 30 35 40 45 50 55 600

20

40

60

80

100 u/t (n=10)

CBLB502 (n=30)

Days

Tu

mo

r-fr

ee m

ice,

%co

ntr

ol

CB

LB

50

2

Control (no drug) CBLB502, 5hrs post injection

• CT26, TLR5-negative syngeneic colon cancer was grown as liver metastases in Balb/c mice

• Tumor growth was monitored using luminometer imager (tumors express luciferase)

Tumor suppressive effect of a single injection

of CBLB502 is associated with tumor infiltration

with immunocytes

immunocyte infiltration

* unpublished data


CBLB502 Against Radiotherapy Side Effects

Toll-like Receptor 5 Agonist Protects

Mice from Dermatitis and Oral

Mucositis Caused by Local

Radiation: Implications for Head and

Neck Cancer Radiotherapy 2

euthanasia required

at 25% weight loss

Cross sections at day 14

Epidermis

Hair

follicle


CBLB502 Oncology Phase I Trial

•Advanced Solid Tumors as a single agent

• Target enrollment 48 pts

• Enrolled first patient March 2012

• Roswell Park Cancer Institute

• PI: Alex Adjei, M.D., Ph.D., FACP, Chair of the

Department of Medicine and Senior Vice President

of Clinical Research at Roswell Park Cancer

Institute

• http://clinicaltrial.gov/ct2/show/NCT01527136?term

=196111&rank=1.

21

http://clinicaltrial.gov/ct2/show/NCT01527136?term=196111&rank=1

http://clinicaltrial.gov/ct2/show/NCT01527136?term=196111&rank=1


CBLB502 only known agonist of TLR5, triggering both pro-

survival mechanisms & innate immune response

22

CBLB502 Competitive Landscape*

Radiation Mitigation

Cellerant (CLT-008) - myeloid progenitor cells targeting hematopoietic system

Aeolus (AEOL 10150) - small molecule antioxidant targeting lung and GI

Neumedicines (HemaMax) - recombinant human IL-12 targeting hematopoietic system

Onconova (ExRad) - modulator of DNA repair pathways targeting overall survival

Araim (ARA290) - short peptide interacting with tissue protective receptor targeting hematopoietic system

RxBio (Rx100) - small-molecule analog of an endogenous, pro-survival molecule targeting overall survival

MedImmune (Amifostine) – cytoprotective agent targeting xerostomia in head and neck cancer

Solgenix (SGX201) – corticosteroid targeting acute radiation enteritis

* Sampling compiled from public data


Protectan CBLB612 Mobilizer of Hematopoietic Stem Cells

23


CBLB612 Overview

• Synthetically produced biologic derivative of Mycoplasma

lipopeptide 5

• TLR2 agonist

• Powerful inducer and mobilizer of hematopoietic stem

cells (HCS) when combined with Standard of Care

• Works synergistically with G-CSF and AMD3100

• Potentially eliminates the need for aphaeresis during BMT

• Potential clinical applications:

• Bone Marrow Transplantation with HSC (without aphaeresis)

• Mitigation of neutropenia

24


Synergistic effect of CBLB612, G-CSF, and

AMD3100 on HSC mobilization*

25

Tota

l C

FC

nu

mb

er

pe

r 1

ml o

f P

B,

x 1

000

CFC - colony-forming cells

HSC - hematopoietic stem cell

4.4x increase over SoC

for neutropenia

6.4x increase over SoC

for bone marrow

transplant

Standard of Care

Neutropenia HSC transplant

* unpublished data


Principle efficacy assessment in Phase I = potential

partnering

26

CBLB612 Product Development Strategy

A Phase I safety study in healthy

volunteers should enable accurate

estimates of induction and mobilization

of stem cells in peripheral blood, a direct

predictor of efficacy of the drug


Curaxins Small Molecule Cancer Therapeutics

27


Curaxins

• Synthetic small molecules with proprietary structure

• Unique molecular target (FACT): simultaneous modulation of three

signal transduction pathways commonly deregulated in cancer:

• Suppression of NF-kB

• Activation of p53

• Suppression of Heat Shock Factor 1

• Efficacious in a broad spectrum of preclinical tumor models

• In vivo efficacy demonstrated for IV and oral routes

• Lack of genotoxicity suggests safe applications including cancer

prophylaxis

• $5 million prestigious Russian government Skolkovo grant awarded

September 2011

28


Recent Peer Review of Curaxins

• Science Translational Medicine (2011)6

“These results introduce FACT as a novel target for anti-cancer therapy. The

broad anti-tumor activity of curaxins, their previously unidentified mechanism of

action – which apparently does not rely on the induction of DNA damage – and

their ability to affect multiple pathways fully justify a continued effort in

evaluating them as anti-cancer agents that could possibly hit the clinic.”

- excerpt from accompanying Perspective by Giulio Draetta (Dana

Farber Cancer Institute) and Ronald DePinho (President, Univ. of Texas

MD Anderson Cancer Center)

• Journal of Virology (2010)7

• Cell Cycle (2009)8

• Oncogene (2009)9

29


CBL0137 Efficacy in multiple human tumor

xenografts in mice 6

30

Caki-1: renal cell

carcinoma

DLD-1: colon

carcinoma

Mel-7: melanoma

PDA: pancreatic

ductal

adenocarcinoma

* - indicates statistical

significance


Synergy of CBL0137 and known cancer therapeutic: Activity

against aggressive tumor in mice*

31

Perc

en

t surv

ival

Days to tumor progression

Data points represent animals at time

periods during which no tumor

progression was measurable

CBL0137 alone

known cancer drug alone

CBL0137 + known cancer drug

* unpublished data


Incuron, LLC – JV for Curaxin Development

• Joint venture with BioProcess Capital Partners LLP, Moscow

• ~$15M to reach inflection points for primary molecules

• CBLI oversees mechanistic studies and formal development

• Ongoing dosing of Phase I trial for prototype CBL0102 in advanced cancer

patients in Russia • Enrolling 5th cohort in dose escalation arm, may continue, as MTD not yet

reached

• Phase I trial with oral formulation of next generation CBL0137 in solid

tumors commencing in Russia

• Optimization of IV formulation of next generation CBL0137 for future trial in

US underway

• Pre-IND mtg. with FDA scheduled for mid-summer 2012

32


Panacela Labs, Inc. Cancer Therapeutics & Anti-infectives

33


Panacela Labs, Inc.

• Joint venture with Open Joint Stock Company “RUSNANO”, $10B

Russian Federation fund

• IP Partners: Roswell Park Cancer Institute, Cleveland Clinic, Children’s

Cancer Institute Australia

• Commitment from RUSNANO: $9M received, $17M over four years,

based on milestones

• Portfolio of five compounds entering formal pre-clinical development or

hit-to-lead optimization

• Strategy – to accelerate human data and licensure via Russian market

and use Phase IV data to expedite approval in U.S. and RoW

34


CBLI Milestones

CBLB502 Defense (all in discussion)

• BARDA development contract

• Start of pivotal animal efficacy studies

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

CBLB502 Medical

• Trial as single agent in advanced cancer patients (enrollment open)

• Trial in head and neck cancer patients (protocol in development/review at Roswell Park)

CBLB612

• Complete formal pre-clinical development (in process)

Incuron

• Complete dosing of CBL0102 trial in Russia (enrolling)

• Phase I trial of CBL0137 in Russia (started)

• IV formulation and pre-clinical development of CBLC137 in US (in process)

General

• High profile peer reviewed publications (some submitted, others in process)

35


Financial Summary

• Shares Outstanding: 36M common, 47M fully diluted

• Government Grants & Contracts support CBLB502 for defense and limited medical applications:

• Continually seeking new grants and contracts as well as modifications to existing grants and contracts to maximize availability of non-dilutive financing

• Cash & Investments at March 31, 2012: $23.6M

• Includes $13M CBLI, $0.5M Incuron, LLC and $10M Panacela Labs, Inc. • Incuron, LLC received ~$1.1M from Skolkovo grant in Jan. 2012

• Other:

• ~$4 million more available from the Skolkovo grant to Incuron, LLC • ~$6.5 million milestone investment into Incuron, LLC triggered by opening of

Russian IND for clinical study of CBL0137 (expected 2Q12)

36


Senior Management Team

Interim Chief Executive Officer

Yakov Kogan, PhD, MBA

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

• Expert in technical sales and contract negotiations

President

Michael Fonstein, PhD

• Scientist and entrepreneur • Founder of The Fellowship for Interpretation

of Genomes (FIG) • Founder and Former CEO of Integrated

Genomics, Inc. (1997-2003)

Chief Financial Officer

Neil Lyons, CPA

• 30 years of financial and operations management and accounting experience

• 6 years as CFO of a public biotech company • 15 years experience in federal contracting

Chief Scientific Officer

Andrei Gudkov, PhD, DSc

• SVP of Basic Science, Roswell Park Cancer Institute

• Former Chair, Dept. Molecular Biology at Cleveland Clinic

• 30+ issued patents • 150+ research publications

Chief Medical Officer Michael Kurman, MD

• 25 years global oncology drug development experience

• Senior positions in clinical operations at CROs • Led clinical development in several publicly traded

biotech companies

Executive Vice President, Regulatory Affairs and Quality Assurance Ann Hards, PhD

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

• Multiple successful NDAs, MAAs, sNDAs, advisory committees


Board of Directors

Independent Directors

Bernard Kasten, MD - Chairman

Former CEO, SIGA Technologies

James Antal, CPA

Former CFO and CIO Experian

Paul DiCorleto, PhD

Chairman Lerner Research

Institute, Cleveland Clinic

David Hohn, MD

Former President, Roswell Park

Cancer Institute

Executive Directors

Yakov Kogan, PhD, MBA

Interim Chief Executive Officer

Michael Fonstein, PhD

President

Andrei Gudkov, PhD, DSc

Chief Scientific Officer


Bibliography

1. Burdelya, et al. (2008) An agonist of toll-like receptor 5 has radioprotective activity in mouse and primate

models. Science 320(5873): 226-230

2. Burdelya, et al. (2011) 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. Radiat. Oncol. Biol. Phys., Oct.14 (e-pub ahead of print)

3. Fukuzawa et al. (2011) A TLR5 agonist inhibits acute renal ischemic failure. J Immunol. 187: 3831-9

4. Yoon et al. (2012) Structural basis of TLR5-flagellin recognition and signaling. Science (in press)

5. Singh et al. (2011) CBLB613: A TLR 2/6 Agonist, Natural Lipopeptide of Mycoplasma arginini , as a Novel Radiation Countermeasure. Radiat Res. Dec 16

6. Gasparian et al. (2011) Curaxins: Anticancer Compounds that Simultaneously Suppress NH-kB and Activate p53 by Targeting FACT. Science Transl Med 3(95):95ra72

7. Gasparian et al. (2010) Inhibition of encephalomyocarditis virus and poliovirus replication by quinacrine: implications for the design and discovery of novel antiviral drugs. J.Virol. 84 (18): 9390-7

8. Neznanov et al. (2009) Anti-malaria drug blocks proteotoxic stress response: anti-cancer implications. Cell Cycle 8(23):3960-70

9. Guo C. et al. (2009) 9-Aminoacridine-based anticancer drugs target the PI3K/AKT/mTOR, NF-kappaB and p53 pathways. Oncogene 28(8): 1151-61

10.Draetta GF, Depinho RA. (2011) Cancer drug discovery faces the FACT. Science Transl Med. 3(95):95ps34

39

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