Investor Presentation

April 1, 2010
 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 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.

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 Mission

CBLI is developing two families of drugs:

Protectans: selectively protect healthy

tissues from radiation damage

Curaxins: kill tumor cells

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 CBLI Summary

• Incorporated in June 2003 Spin-off from the Cleveland Clinic

• HQ - Buffalo, NY 36 full time employees (majority PhDs & MDs)

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

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

IP
• ~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 cancer

treatment side effects
– Potential to compete with G-CSF ($5+ billion drug from
Amgen)

• Curaxins: Broad range anti-cancer drugs

– $50 billion growing market 5
 The Threat - Nuclear Attack

• A nuclear 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)

There is no approved drug which can

effectively protect from ARS
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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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 Recent Milestones – CBLB502

• Phase I ascending-dose safety trial successfully

concluded June 2009

• $32 million in development contracts from DoD and

BARDA/HHS and NIAID/NIH received in 2008/2009
(~$21 million left + proposals for ~$30 million in
additional funds pending)

• DoD RFP published December 2009 for advanced

development and procurement of doses

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 CBLB502: Mechanism of Action

IAPs, Bcl-2 Suppress apoptosis

CBLB502 TLR5 NF-kB SOD2, ferritin Inactivate ROS
Cytokines Promote regeneration

CBLB502 mobilizes multiple mechanisms of

radiation defense, all stemming from TLR5
activation

CBLB502 protects from both gastrointestinal

and hematopoietic components of radiation
death
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 A New Principle of Radioprotection

• Published in Science -
April 11,2008

• Validates mechanisms of action of

the drug and protective effect on
mice & primates

• First Science 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 Efficacy: Survival (Mitigation) after LD70 IR
100
Non-human primates
80

% of survivors
60

40

vehicle (PBS), n=8

20 CBLB502 @ +16h, n=12
CBLB502 @ +25h, n=10
CBLB502 @ +48h, n=12
0
0 10 20 30 40
Days after 6.5 Gy gamma-TBI

TBI, Gy Injections N N % survival P-value vs.

total survivors vehicle
6.5 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% -

Effective when injected up to 48 hours after radiation 11

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

• 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)

Established FDA pathway to approve drugs where

efficacy is unethical to test in humans
Dramatically reduces development time and costs
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 CBLB502 – ARS: CMC Effort

Laboratory Preclinical & Clinical

Strain Studies

Formulation
Manufacturing
Production Strain, DSP

GMP process developed Fermentation

Drug released Improvement

MBF
Cell Bank

QC protocols, stability Bioassay Test Residuals

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CBLB502 – ARS: Summary of Primate Studies
Time relative to TBI (if applicable)
TBI Dose Parameter
-45' +1h +16h +25h +48h +72h
Survival benefit +40% +45% +45% +40%-60% +45% TBD
Thrombocytopenia reduction +++ +++ +++ +++ +++ +++
Neutropenia reduction + ++ ++ ++ + +

19 studies with over 700

LD60-70 Improved BM, spleen, thymus
Improved GI mucosa
+++
++
+++
+++
+++
Ongoing
+++
Ongoing
+++
Ongoing
TBD
TBD

primates tested dose-

Cytokine release (G-CSF, IL-6, etc.)
Data on dose dependence of efficacy
+++
√
+++
√
+++
TBD
+++
Ongoing
+++
TBD
TBD
TBD
Thrombocytopenia reduction +++ +++ +++ +++ +++ ++

LD10-20
dependence for the drug,
Neutropenia reduction + ++ ++ ++ + +
Cytokine release (G-CSF, IL-6, etc.) +++ +++ +++ +++ +++ ++
efficacy time window and effects
Data on dose dependence of efficacy Ongoing √ TBD TBD TBD TBD
Increased platelet levels +++

No TBI
of various radiation doses
Increased neutrophil levels ++
Cytokine release (G-CSF, IL-6, etc.) +++
Data on dose dependence of efficacy √

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

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 Summary of Phase I trial of CBLB502
• 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
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 Protectan CBLB502: Development Timeline
Manufacturing GMP manufacturing Process
Manufacturing of Consistency Lots
& (>100,000 doses) validation
Formulation Development & Stability Studies
Stability Studies of the Final Product
of Lyophilized Formulation

Non-Clinical GLP Acute GLP 2-week

Mouse & Primate Reprotox Studies in Reprotox Studies in
Safety Mouse & Primate
Toxicology Studies Rabbits & Rats-Seg. II Rats-Seg. I&III
Toxicology Studies

Non-Clinical Efficacy in Mice, Mechanism of Action; Pivotal GLP Mouse& Primate

Efficacy Rats and Primates Markers of Efficacy Efficacy Studies to support NDA filing
Start BLA
Filing
Clinical/ IND Dose Escalation Phase II Safety Trial
Regulatory Filed Trial - Phase Ia Ph IIA (100 subjects) & Ph IIB (~500 subjects)
(50 volunteers)

Federal grant support from

Completed DoD and HHS/BARDA
2004 10/09 Q4’10

- - Currently concluding second human safety trial

- Expect to complete all other remaining requirements
needed for FDA in 2010/2011

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CBLB502 - ARS Market Potential “Back of the Envelope”

Primary sales targets: Need understood, concepts of use

developed, high degree of financial commitment,
relations with CBLI in place
• DoD - 2 million potential doses for US military
• BARDA/HHS - 5-20 million potential doses for protection
of US civilians (Strategic National Stockpile)
Secondary sales targets: Serious public concern, policies
being developed
• Israel, UK, Canada, India, China, Japan, S. Korea

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

No competing products today
RFP from DoD indicates commitment to procurement
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CBLB502: Protection from Local Irradiation
3x10 Gy daily

110 10 Gy x3 (CBLB502 + 10 Gy) x3

3x10 Gy daily with CBLB502 pretreatment
100
Body weight, %

90

80

70

60
0 5 10 15
Days

Strong mitigation of radiological damage of healthy

tissues shown in mouse model of head-and-neck
damage directly supports first medical trial 19
CBLB502: Phase I/II Head & Neck Human Trial

• Open IND
• Funded by $5.3 million stimulus grant
received September 2009
• Protocol submitted to IRB
• Planned to start at Roswell Park Cancer
Institute 2010
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Protectan CBLB612
Stem 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.,myelodysplastic

syndrome)

Opportunity for combination with or substitute for

G-CSF
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CBLB612: Supportive Care During Chemotherapy
WBC
White Blood Cells
30.00

25.00

20.00
10x3/ul

15.00

10.00

5.00

0.00
day -5 day7 day14 day22
CBLB612 10.33 2.66 3.09 14.73
PBS 9.65 1.98 0.43 7.21

Dramatic improvement of blood recovery during

Cyclophosphamide treatment in mice
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 CBLB612 Induces Propagation of HSCs

CBLB612 or
G-CSF

CBLB612 is 6x more efficacious than G-CSF and

induces both early and late progenitor cells.
Effects of CBLB612 and G- CSF are synergistic 24
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
Zhejiang Hisun Pharmaceutical license for China
signed Sept. 2009
($1.65M upfront development, 10% royalties)

Principle efficacy assessment in Phase I =

potential partnering
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Curaxin Product Line
Anti-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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 INCURON – JV for Curaxin Development

• 50/50 joint venture with Bioprocess

Ventures, Moscow

• ~$18M to reach Phase II for new

generation of Curaxins

• CBLI to serve as subcontractor to oversee

mechanistic 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 support

CBLB502 for defense and medical applications (at 12/31/09):
$16M
– Pending proposals for additional grants and contracts to support all CBLI
programs: $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 29

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 CBLI Management Team
Chief Executive Officer & President
Michael Fonstein, PhD
• 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)
Chief Financial Officer
Jack Marhofer, MBA, CMA, CFM
• 20 years of financial and
accounting experience
• 8 years as a corporate
controller of a public company
Chief Operating Officer
Yakov Kogan, PhD, MBA
• Former Director of Business
Development at Integrated
Genomics, Inc.
• Expert in technical sales and
contract negotiations
Chief Scientific Officer
Andrei Gudkov, PhD, D.Sci
• 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
Vice President, Drug Development
Farrel Fort, PhD, MBA, DABT
• 30 years of Pharma experience
• Former Director of Drug Safety
at TAP Pharmaceuticals, Inc.
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 CBLI Boards
Board of Directors Scientific Advisory Board
Independent Directors George R. Stark, PhD
Bernard L. Kasten, MD Chairman of SAB, Member of NAS, Former director of LRI,
Former CEO, SIGA Technologies Scientific Advisor to Amersham and Genentech, pioneered
numerous major research technologies
Daniel Perez, MD
Former CEO & President of Berlex Biosciences, Inder Verma, PhD
a Division of Bayer AG Member of NAS, Professor of Salk Institute, Founder and
Scientific Advisor to Cell Genesys, Signal Pharmaceuticals,
James Antal, CPA, MBA UroGenesys, Ventana Pharmaceuticals, Quark Biotech.
Former CFO and CIO of Experian Internationally recognized leader in cancer biology and
Paul DiCorleto, PhD inflammation
Chairman, Lerner Research Institute
Bruce Blazar, MD
Management Professor, Chair in Transplantation Immunology of
Michael Fonstein, PhD University of Minnesota. Member of the FDA Advisory
CEO & President, Cleveland BioLabs, Inc. Committee, SAB member of BioMarin Pharmaceutical,
Seattle Genetics, etc.
Andrei Gudkov, PhD, DSci
CSO, Cleveland BioLabs, Inc

Yakov Kogan, PhD, MBA

COO, Cleveland BioLabs, Inc
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