Rodman & Renshaw 16th Annual

Global Investment Conference NASDAQ: CBLI

September 10, 2014

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

CBLI Today

A clinical-stage biopharma company with a portfolio of

innovative drugs for radiation defense and oncology

• Medical radiation countermeasure (MRC) for rescue therapy following radiation disasters (Entolimod-MRC)

• Cancer immunotherapy targeting innate immunity receptor TLR5 (Entolimod-Oncology)

• Multi-targeted chemotherapy (Curaxin-CBL0137)

• Supportive care treatment for oncology: hematopoietic stem cell (HSC) propagator and mobilizer targeting innate immune receptors TLR2/6 (CBLB612)

3

Product Pipeline

4

PRODUCT

Indication

Entolimod-Oncology

Advanced Solid Tumors

CURAXIN CBL01371

Solid Tumors and Lymphoma

CBLB612

Neutropenia/HSC mobilization

DISCOVERY/PRE-CLINICAL

PROGRAMS

DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III

PRODUCT

Indication

ENTOLIMOD-MRC

Acute Radiation Syndrome

DISCOVERY PRECLINICAL PIVOTAL ANIMAL

STUDIES

HUMAN SAFETY

STUDIES

Leading product development programs

1Developed by Incuron, LLC subsidiary

• Pre-Emergency-Use Authorization (pre-EUA) and commercialization for pivotal-stage radiation countermeasure, Entolimod-MRC

• Recent meeting with FDA confirmed existing efficacy and safety data and animal-to-human dose conversion are sufficient to submit pre-EUA application

• Pre-EUA status will facilitate commercialization prior to full licensure

• Value-driving data and partnerships for two Phase 1 oncology drug candidates with novel targets and broad applications in areas of unmet needs

• Entolimod-Oncology: confirm immune-stimulatory effects as a single agent or in combination with marketed immunotherapy

• Curaxin CBL0137: increase value as an oncology treatment through targeted Phase 2 monotherapy efficacy studies supporting accelerated approval

• Leveraging unique clinical and business connections in the Russian Federation to secure asset-specific funding and expedite clinical trial execution

• Approximately $23M in program funding from government development grants and contracts

• Access to top oncology centers

5

CBLI Is Focused on Achieving Major

Strategic Objectives

Entolimod

Medical Radiation Countermeasure (MRC) for Rescue Therapy Following Radiation Disasters

&

Cancer Immunotherapy

6

• Activation of TLR5 in normal tissues leads to

primary innate immune response

• Additional direct cytotoxicity to TLR5+ tumors

• Modifies microenvironment in liver, lungs, and

bladder to suppress TLR5+ and TLR5- metastases

• Massive mobilization of immunocytes to liver

• Adaptive immune response for prolonged antitumor

effect

• Protects from radio- and chemotherapy side effects

• Currently in Phase I trial

CBLI is Leveraging Mechanistic Effects of

Entolimod for Dual Indications

Cancer Treatment

• MRC that ameliorates hematological and

gastrointestinal injury, tripling survival after highly

lethal whole-body radiation

• Easy-to-use, single, intramuscular injection

administered ≥24 hours after radiation protects

against radiation injury

• No other supportive care required

• Suitable for stockpiling

• Pivotal efficacy study complete

• Eligible for pre-EUA submission to FDA

Medical Radiation Countermeasure (MRC)

healing cytokines

anti-infective factors

anti-oxidative factors

anti-apoptotic factors neutrophils macrophages monocytes T-cells dendritic cells

protection/mitigation of radiation damage

cancer treatment

Entolimod TLR5 NF-kB

mobilization of:

7

Entolimod Addresses a High Unmet Public

Health Need

• Nuclear attack has been identified by US and global leaders as the

greatest potential security threat

• >100,000 people could die from radiation injuries if a 10-megaton nuclear

device was detonated in a major city

• The Fukushima disaster highlights the risks of an industrial accident

• People subjected to potentially lethal irradiation will suffer from

neutropenia, thrombocytopenia, anemia, infection, bleeding, and

gastrointestinal dysfunction over 3 to 5 weeks

• A medical radiation countermeasure (MRC) is needed that can be

administered after irradiation to ameliorate radiation injury

• No MRC has been approved by the FDA

8

Entolimod Has Achieved Pivotal Development

Status Under the FDA Animal Rule

• Successful completion of pivotal efficacy study in non-human primates

• Characterization of safety in 150 healthy subjects and 25 patients with advanced cancers

• Completion of formal animal-to-human dose conversion to select a human dose

• Development of a high-yield cGMP manufacturing process

• Manufacturing of sufficient material for >1,000,000 doses

• Demonstration of prolonged drug stability

• Formulation in single-use vials suitable for stockpiling by civil and military defense agencies

9

Entolimod Prevents Radiation-Related Death

in Non-Human Primates

A single dose of entolimod administered 25 hours after irradiation

protected against radiation-related mortality occurring 2-3 weeks later

0 7 14 21 28 35 42 49 56 63

0

10

20

30

40

50

60

70

80

90

100

T im e , d a y s

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10

Entolimod Doses ≥10 µg/kg Shows Highly Significant

Survival Advantages in Non-Human Primates

Entolimod increased survival by ~3-fold

(47.5% absolute improvement: from 27.5% to 75%)

0

10

20

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E n to lim o d D o s e , g /k g ( In it ia l N )

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120 (

N=

20)

E m a x P re d ic t io n

P = .0 0 2 1

P < .0 0 0 1

P < .0 0 0 1

~3-fold

increase

in survival

11

Entolimod Induces Hematological Improvements in

Neutrophils, Platelets, and Red Blood Cell Parameters

Entolimod doses ≥10 μg/kg improved hematological nadirs

(P=.0149 to P=.0005) and the proportion of days alive and free of severe

cytopenias and anemia (P<0.0001 for all tests)

0 7 1 4 2 1 2 8 3 5

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/L

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5

12

• CBLI met with the FDA in July 2014

• FDA indicated to CBLI that the existing entolimod efficacy, safety, and animal-to-human dose-conversion data are sufficient for FDA review

• CBLI is in discussions with US government agencies to:

• Obtain co-sponsorship and support for a pre-EUA submission

• Solicit ongoing funding for pursuit of full licensure

• Ensure entolimod meets requirements for stockpiling

• CBLI is targeting 1H2015 for pre-EUA submission to FDA

13

CBLI Has Received a Green Light from the FDA

to Submit a pre-EUA Application

Entolimod-Oncology

Cancer Immunotherapy

14

Cancer Immunotherapy is a Growing Opportunity

• Market for cancer immunotherapy in major world

markets is set to grow from a value of $1.1 billion

in 2012 to nearly $9 billion in 20221

• Combination approaches offer the potential for

improved therapeutic outcomes in a broader

range of tumor types2

• Pharma companies are focusing on cancer

immunotherapy

• Merck, BMS, Roche, Novartis, AstraZeneca and

others are developing checkpoint inhibitors for

multiple solid tumors

1 Source: Decision Resources Group

2 Mellman et al. Nature. 2011; 480:480-489

15

Entolimod Offers Potential as an Alternative

or Adjunctive Immunotherapy

• Activation of TLR5 in normal tissues -- induces innate immune response with potent antitumor activity in preclinical models

• Independent of TLR5 expression by tumor

• Uniquely differentiated by homing immune response to TLR5 expressing organs (liver, lung, bladder, etc.)

• Allows recruitment of secondary adaptive response for prolonged antitumor effect

• Potential for combinations with emerging class of active immunotherapy agents (adding “auto-vaccination” of personal tumor to non-specific T-cell activation provided by immune checkpoint inhibitors)

• Systemic entolimod

• Local (intravesical) entolimod

• Bladder cancer

16

Entolimod (CBLB502) Suppresses Metastases and Mobilizes

Adaptive Immune Response for Prolonged Antitumor Effect

Transplanted breast or colon tumors grown in mice

Surgically remove primary tumor

CBLB502 treatment on Days 1, 3, & 5 post surgery

4 T 1 P o s t-S u r g e ry M e ta s ta t ic S e tt in g

0 2 0 4 0 6 0 8 0 1 0 0

0

2 5

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P B S (n = 2 2 )

T im e P o s t -S u rg e ry (D a y s )

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*

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CT26 tumor-free mice (liver)

0 20 40 600

20

40

60

80

100 Intact, n=15

CBLB502, n=19log rank p=0.0067

Days

Perc

en

t su

rviv

al

livermetastase

liver

metastase

Control (no drug) CBLB502, 5hrs post injection

Intact

Anti-Fas

CBLB502

+ anti-Fas

control

CBLB502

Control (vehicle) CBLB502

colon cancer CT26 breast cancer 4T1 Metastatic growth of:

colon cancer CT26

Re-challenge of survivors

by SC injection of tumor

cells of the same type

17

Entolimod Is in Phase 1 Testing to Evaluate

Safety and Systemic Immune Cell Responses

• Ongoing Phase 1 study in patients with advanced cancer in

the United States • Primary goal was to define safety profile in patients with cancer

• Study evaluated immune cell activation (T-cell subsets, neutrophils, NK

cells) before onset of neutralizing antibodies

• Reached MTD at 6th cohort; anticipate completion of dosing in Sep 2014

• Pending Phase 1 study in patients with advanced cancer in

the Russian Federation • Enrollment of additional patients at the highest doses achieved in

the US study

• Further evaluation of immune cell activation planned

• Partially funded by Russian government contract

• Anticipated to start 4Q2014

18

Non-invasive Bladder Cancer Represents a

Major Opportunity for Entolimod Therapy

Incidence: • Fourth most common cancer in world

• Estimated global prevalence of

2.7 million

• U.S. 2013 incidence of bladder

cancer approximately 73,000 with a

prevalence of over 500,000

Need:

• ~$4 billion is spent on treatment each

year in the US

• Despite BCG, there is a high local

recurrence rate with >50% recurring

within 2 years and ~75% recurring

within 5 years

• Patients with BCG-refractory

progressive disease require total

cystectomy and may develop life-

threatening metastases

Opportunity: • FDA is focused on finding new

therapies

• TLR5 is expressed in bladder

• Induction of TLR5 is potentially less

toxic than TLR4

• Entolimod may have direct cytotoxic

effects in TLR5+ bladder cancers

• Opportunity for early proof of concept

(6-12 months) based on cystoscopy

• Potential for accelerated approval

Standards of Care: • Following surgery, adjuvant intravesical

immunotherapy is administered

• BCG (TLR4 agonist) is the accepted

intravesical immunotherapy – live

bacteria with high-risk profile and

serious adverse events

19

Orthotopic Bladder Carcinoma Mouse Model: C57BL/6 mice with intravesically injected

MB49 (TLR5-negative) bladder cancer cells. Intravesical treatment with entolimod on Days 4

& 5 after tumor implantation resulted in:

Activation of NF-kB response in bladder epithelium

Massive infiltration of immune cells in the tumor

Tumor growth suppression

Extended survival

Un

trea

ted

C

on

tro

l

Intr

aves

ical

En

tolim

od

TM

Intravesical Saline

Intravesical Entolimod

NFkB activation (p65 translocation)

Activated immune cell accumulation in

bladder tumor (CD11b+)

Entolimod for Intravesical Treatment of

Bladder Cancer

20

Tumor Size Changes

Curaxin CBL0137 Small Molecule Cancer Therapeutic

21

CBL0137 Overview

• Synthetic small molecule with proprietary structure

• New chemical entity with fully characterized structure-activity relationship

• Drug action addresses nearly ubiquitous but difficult-to-target mechanisms involved in tumor proliferation and resistance

• Pre-clinical efficacy as monotherapy and in combination therapy across broad spectrum of tumor types (including tumors resistant to currently available drugs)

• Solid tumors: non-small-cell lung cancer, breast cancer, colon cancer, pancreatic cancer, renal cell cancer, prostate cancer, melanoma, glioblastoma, neuroblastoma

• Hematologic cancers: lymphoma, multiple myeloma, acute lymphocytic leukemia

• Formulated for oral and IV administration

• Ongoing Phase 1 studies

• Robust WW patent portfolio

22

FACT Is the Molecular Target of CBL0137

• FACT (Facilitates Chromatin Transcription) is a two-subunit chromatin remodeling complex consisting of SPT16 and SSRP1

• FACT serves as a transcription elongation factor that disassembles nucleosomes ahead of RNA Pol II, reassembling them after transcription

• When trapped in chromatin, FACT binds and changes substrate specificity of CK2, which then phosphorylates SSRP1 and p53

• FACT is essential for emergency pathway activity (ie, NF-kB and HSF-1-mediated transcription), but is not needed for expression of constitutively active genes

• FACT is a marker of aggressive cancers and cancer stem cells

• FACT repression is selectively toxic for tumor cells

Garcia et al., Cell Rep. 2013, 4:159-73

23

FACT Overexpression in Tumors

Breast Cancer Survival by FACT Expression

Non-genotoxic DNA intercalation of CBL0137 traps FACT, leading to

simultaneous inhibition of NF-κB, HSF-1 and HIF-1a, and expression of p53

CBL0137 Mechanism of Action

free FACT

Curaxin

Trapped

FACT

CKII

NFkB, HSF1, HIF1a

promoters

transcription

NFkB, HSF1, HIF1a

promoters

No free FACT, no transcription

Curaxin’s intercalation leads torsion stress

Formation of alternativeDNA structures, trapping FACT, CKII-mediated p53 activation

p53* p53*bound FACT

p53* p53*

24

25

CBL0137 Is Active in All Cancer Models Tested

• CBL0137 is also effective in in vivo models of NSCLC, breast cancer, prostate

cancer, glioblastoma, lymphoma, and multiple myeloma

• CBL0137 is effective against drug-resistant tumors

• No CBL0137-resistant tumor has been identified

CBL0137 Phase 1 Development Program Is in Progress

in Patients with Solid Tumors or Lymphomas

Oral Administration

Russia

QD x 14 days with 14 days off

• 8 dose levels evaluated (4 mg/m2 through 56 mg/m2)

• 24 patients accrued

• Orally bioavailable

• No MTD yet established

Intravenous Administration

United States

Weekly x 3 weeks with 1 week off

• 5 dose levels evaluated (10 to 60 mg/m2)

• 16 patients accrued

• No DLTs

• No MTD yet established

• CBLI is also collaborating with the NCI Cancer Therapy Evaluation

Program (CTEP)

o Performing screening for activity in Pediatric Preclinical Testing Program

o Preclinical efficacy in childhood cancers (neuroblastoma, glioblastoma, and

ALL) supports an initiative with the Children’s Oncology Group to consider

pediatric Phase 1 evaluation early after achievement of an adult MTD

26

CBL0137 Development will be Focused on Indications that

Could Lead to Accelerated Regulatory Approval

Expression of target

by tumor type

In vitro activity

Xenograft efficacy

Indications:

- Preclinical support

- High unmet need

- Safety profile acceptable

- Opportunity to demonstrate single-agent activity in Phase 2

- Potential to combine with SOC in Phase 3

Planning toward:

1. Accelerated

approval as a

single agent

2. Full approval

alone or in

combination

Indication 1

Indication 2

Indication 3

Evolving clinical safety,

pharmacology,

& efficacy

Non-clinical

pharmacology &

toxicology

27

Several Indications May Deserve Clinical

Priority

Potential for Phase 2 monotherapy efficacy

supporting accelerated approval and future

combination with (noncytotoxic) drug in Phase 3

Targeting of segments of major tumor types

with high unmet need in which

CBL0137 safety profile may be acceptable

Speed-to-Approval Indications Speed-to-Peak-Sales Indications

• Recurrent high-grade glioma (adult, pediatric)

• Previously treated pancreatic cancer (2nd-line)

• Previously treated hepatocellular cancer (2nd-line)

• Previously treated renal cell cancer (3rd-line)

• Refractory lymphoid cancers (eg, diffuse large B-cell

lymphoma [DLBCL], acute lymphocytic leukemia

[ALL], or multiple myeloma [MM]*)

• Previously treated, non-small-cell lung cancer

(NSCLC) (3rd-line)

• Previously treated, colorectal cancer (3rd-line)

28

CBLB612 Mobilizer of Hematopoietic Stem Cells

29

CBLB612 Overview

• Synthetically produced biologic with

proprietary structure, a derivative of Mycoplasma lipopeptide

• Agonist of innate immunity receptor TLR2/6; acts by mobilizing natural mechanisms and boosting immune response

• Powerful inducer and mobilizer of hematopoietic stem cells (HSC) when combined with standards of care

• Potential clinical applications:

• HSC harvesting in support of transplantation in oncology and biodefense

• Potential elimination of leukapheresis for HSC collection

30

CBLB612

TLR2/6

Signaling

cascades

GSCF IL-8 IL-10 IL-6

PBSC & progenitors

Neutrophils Platelets

Inflammation

CBLB612 Stimulates and Protects HSC

Spleen preservation

following irradiation

Long-term HSC following CBLB612

CBLB612

31

CBLB612 Synergizes with Filgrastim (G-CSF) and

Plerixafor (AMD3100) to Mobilize HSC in Mice* To

tal C

FC

nu

mb

er

pe

r 1

ml o

f P

B, x 1

00

0

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

32

Addition of CBLB612 to Mobilization Regimen

Enhances Survival after Total Body Irradiation

Transfusion of only 11 µL of peripheral blood from

CBLB612-mobilized animals rescued 100% of lethally irradiated mice

33

Phase 1 Clinical Development is Planned

Mobilization data are expected to provide clinical

proof-of-concept in support of partnering for further development

• Phase I study in healthy volunteers is expected to start

in 3Q2014 and be completed by 4Q2015

• Goals:

• Establish MTD

• Document safety profile and pharmacokinetics

• Characterize type, quantity, and timing of HSC mobilization

34

CBLI Development Milestones and Financial Summary

35

Development Milestones Planned 2014-2015

2014 2015

Q3 Q4 Q1 Q2 Q3 Q4

Entolimod - MRC:

Pre-EUA filing X

Entolimod- Oncology:

Ph 1 advanced cancers LPO (US) X

Ph 1 advanced cancers data reported (US) X

Ph 1 IND open, advanced cancers (RF) X

Ph 1 advanced cancers, LPO (RF) X

Ph advanced cancers data reported (RF) X

CBL0137:

Ph1 oral, interim read out X

Ph1 oral, LPO X

Ph1 oral, data reported X

Ph 1 i.v., LPO X

Ph 1 i.v., data reported X

CBLB612:

Ph 1 IND Open, healthy volunteers (RF) X

Ph 1 healthy volunteer LPO X

36

Pro Forma Financial Summary (as of June 30, 2014)

47% 54.6%

• Shares outstanding

Basic: 57M

Fully-Diluted: 84M

Cash: $13.4M

BioLabs 612 100%

$s in millions (1)

CBLI

Majority-Owned

Subsidiaries Total

Cash & investments, consolidated $ 7.7 $ 3.4 $ 11.1

Contract & grant funding available (2)

2.8 2.8 5.6

Contract awards, not yet funded (3)

2.5 2.3 4.8

Financial Partner commitments (4)

- 2.3 2.3

Financial Partner options (5)

- 15.5 15.5

Total $ 13.0 $ 26.3 $ 39.3

(4) Amount represents remaining commitments contributed on August 1, 2014

(1) Amounts payable in foreign currencies are quantified based on the period-end exchange rate.

(2) Amounts represent contract & grant funded awards, less cash receipts to date.

(3) Amount represents awards made for future periods of currently active contracts, not yet funded.

(5) Amount represents optional future contributions the financial partner can make to subsidiary.

37

Rodman & Renshaw 16th Annual

Global Investment Conference NASDAQ: CBLI

September 10, 2014