36
2015 Annual Meeting of Stockholders NASDAQ: CBLI April 14, 2015

2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

2015 Annual Meeting of Stockholders NASDAQ: CBLI

April 14, 2015

Page 2: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

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

Page 3: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Agenda

• CBLI Today

• Achievements

• Clinical Updates

• Financial Update

• Milestones

3

Page 4: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

CBLI Today

A clinical-stage biopharma company with a

portfolio of investigational 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)

• Supportive care treatment for oncology: hematorestorative agent targeting

innate immune receptors TLR2/6 (CBLB612)

• Cancer immunotherapy delivered locally via a non-replicating recombinant

adenovirus vector expressing TLR5 and ligand (Mobilan)

• Multi-targeted cancer therapeutic with novel mechanism of action

(CBL0137)

4

Page 5: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

CBLI’s Corporate Structure

Entolimod MRC

Entolimod Oncology

CBLB612

CBL0137 Mobilan

Russian Federation Operations

BioLab 612

47% 58% 100%

5

Page 6: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Product Pipeline (CBLI & Joint Ventures)

6

PRODUCT

Indication

ENTOLIMOD*

Acute Radiation Syndrome

(pre-EUA)

DISCOVERY PRECLINICALPIVOTAL ANIMAL

STUDIES

HUMAN SAFETY /

DOSE CONVERSION

CBLI

INCURON

PANACELA

PRODUCT

Indication

CBL0137

Advanced Solid Tumors

DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III

PRODUCT

Indication

ENTOLIMOD-Oncology

Advanced Solid Tumors

CBLB612

HSC Mobilization

DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III

PRODUCT

Indication

MOBILAN

Prostate Cancer

DISCOVERY PRECLINICAL PHASE I PHASE II PHASE III

Page 7: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

• Pre-emergency-use authorization (pre-EUA) and commercialization for

Entolimod-MRC

• Pre-EUA status facilitates commercialization prior to full licensure

• On track for submission of pre-EUA to FDA in 2Q15

• Development of value-driving data and partnerships for Phase 1 oncology

drugs with novel targets and broad applications

• Entolimod-Oncology: confirm immune-stimulatory effects as a single agent or in

combination with marketed immunotherapy

• CBLB612: evaluate ability to ameliorate chemotherapy-induced myelosuppression

• Mobilan: evaluate ability to induce innate immunity in prostate cancer patients

• CBL0137: increase value as an oncology treatment by demonstrating effect in

patients with advanced disease

7

CBLI Is Focused on Achieving Strategic

Objectives

Page 8: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

We Have Advanced Our Programs Over the

Past Year

Entolimod (CBLB502) Radiation Countermeasure

• Successful FDA meeting regarding dose conversion and potential pre-EUA

submission

• DoD recommended funding of two CBLI proposals to support further

development of entolimod towards BLA

• Compiled pre-EUA submission for FDA – on track for submission in 2Q

• Opened dialogues with select foreign governments for potential purchase

Entolimod (CBLB502) Oncology

• Completed dosing in advanced cancer trial at RPCI • Data submitted for poster presentation at ASCO

• Opened follow-on study in Russian Federation to further evaluate immune

cell response at highest dose levels achieved in RPCI study and

supplement safety database for radiation indication

• Evaluating potential clinical directions for next stage of development

8

Page 9: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

We Have Advanced Our Programs Over the

Past Year

CBLB612

• Completed dosing in Phase I study in healthy subjects in Russian

Federation

• Designed Phase 2a study for prevention of chemotherapy-induced

myelosuppression (supported by Russian government contract)

Mobilan

• Opened IND in Russian Federation for Phase 1 study in patients with

prostate cancer (supported by Russian government contract)

CBL0137

• Dosing 8th dose cohort in Phase 1 IV study in US

• Dosing 9th dose cohort in Phase 1 oral study in Russian Federation

• Reported interim safety data and efficacy data indicating disease

stabilization in several patients with advanced cancers

9

Page 10: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Clinical Development Update Langdon Miller, MD -Strategic Medical Advisor

10

Page 11: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Entolimod

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

&

Cancer Immunotherapy

11

Page 12: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

CBLI on Track to Submit a pre-Emergency Use

Authorization Application in 2Q15

• CBLI received a green light from FDA to submit a pre-EUA Application:

• 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 support for a pre-EUA submission

• Solicit ongoing funding for pursuit of full licensure

• In contract negotiations with Dept. of Defense for two CBLI proposals

• Ensure entolimod meets requirements for stockpiling

• Estimated pre-EUA review/feedback from FDA in 2H15 (no PDUFA timeline)

Pre-Emergency Use Authorization (pre-EUA) facilitates

commercialization prior to full licensure

12

Page 13: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Market Potential for Entolimod as a Medical

Radiation Countermeasure Is Significant

• Landscape

• The only currently stockpiled drug for radiation rescue is filgrastim

(Neupogen®), which demonstrates variable survival efficacy, must be self-

administered over 2 weeks and requires laboratory monitoring

• Entolimod’s drug profile is much better aligned with the USG’s specifications

for a high-efficacy drug that offers convenient single-dose administration and

requires no follow-up monitoring or supportive care

• Procurement

• The Strategic Reserve Fund established by Project BioShield, acquires for the

Strategic National Stockpile (SNS) – current annual budget $560M

• To date, $3.3B in procurement contracts have been issued for anthrax,

botulism, smallpox and nerve agents ranging in size from $18M - $700M with

mean/median awards of $301M/$220M, respectively

• Most existing SNS purchases have been based on pre-EUA approval, i.e. the

drugs were not licensed for the named indication

13

Page 14: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

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

• Pharma companies are focusing on cancer

immunotherapy

• Merck, BMS, Roche, Novartis, AstraZeneca and

others are developing checkpoint inhibitors for

multiple solid tumors

• Combination approaches may offer the potential

for improved therapeutic outcomes in a broader

range of tumor types2

1 Source: Decision Resources Group

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

14

Page 15: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Entolimod Offers Potential as an Alternative or

Adjunctive Immunotherapy

• Activation of TLR5 induces innate immune response in normal

tissues and potent antitumor activity in preclinical models

• Immunocytes mobilize to organs with high TLR5 expression (liver,

lungs, bladder)

• Induces a secondary adaptive response for prolonged antitumor

effect

• May offer therapeutic benefit via two different routes

• Systemic administration

• Potential for combinations with other emerging immunotherapy agents

(e.g., immune checkpoint inhibitors)

• Local (intravesical) administration for bladder cancer

15

Page 16: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Entolimod Suppresses Metastases and Mobilizes Adaptive

Immune Response for Prolonged Antitumor Effect

Transplanted breast or colon tumors grown in mice

Surgically remove primary tumor

Entolimod 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

5 0

7 5

1 0 0

1 g C B L B 5 0 2 (n = 2 0 )

P B S (n = 2 2 )

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

Su

rv

iva

l, %

*

*p < 0 .0 1 to P B S

R e -c h a lle n g e o f 4 T 1 T u m o r - fre e M ic e

T im e P o s t Im p la n t, D a y sS

urv

iva

l, %

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

0

2 5

5 0

7 5

1 0 0N aive

P B S

E n to lim o dT M

-c u re d

*

*p < 0 .0 0 1

n = 9

n = 3

n = 1 4

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

5 0

7 5

1 0 0

1 g C B L B 5 0 2 (n = 2 0 )

P B S (n = 2 2 )

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

Su

rv

iva

l, %

*

*p < 0 .0 1 to P B S

R e -c h a lle n g e o f 4 T 1 T u m o r - fre e M ic e

T im e P o s t Im p la n t, D a y s

Su

rv

iva

l, %

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

0

2 5

5 0

7 5

1 0 0N aive

P B S

E n to lim o dT M

-c u re d

*

*p < 0 .0 0 1

n = 9

n = 3

n = 1 4

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

colon cancer CT26

Re-challenge of survivors

by SC injection of tumor

cells of the same type

16

Entolimod Entolimod

Entolimod

Entolimod-cured

Entolimod

Page 17: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Entolimod Is in Phase 1 Testing to Evaluate Safety

and Systemic Immune Cell Response

• Completed Phase 1 study in patients with advanced cancer

in the United States

• Preliminary analysis indicates tolerability profile similar to that observed in

healthy volunteers

• Entolimod induced TLR5-dependent immune cell activation (T-cell subsets,

neutrophils, NK cells), as assessed at higher dose levels

• Several patients with heavily pretreated cancers had stable disease

• Data were submitted to 2015 American Society of Clinical Oncology (ASCO)

annual meeting

• Ongoing 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

• Dosing started December 2014; recruitment expected to complete 2Q15

17

Page 18: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Combinations with Emerging Immunotherapeutics

Represent Important Opportunities for Entolimod

• Immune checkpoint inhibitors have

established clinical efficacy in multiple

cancer types

• However, overall response rates are

typically 20 to 30%, meaning 70 to

80% of patients have tumors that do

not respond

• New, combination immunotherapies

are needed to improve outcomes for

patients

• Entolimod mobilizes antitumor innate

and adaptive immunity to several

body sites (particularly, liver)

• Stimulation of T-cells has been

confirmed in the entolimod Phase 1

trial

18

Page 19: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Non-invasive Bladder Cancer Represents a

Major Opportunity for Entolimod Therapy

• Bladder cancer is the 4th most common cancer in the world

• US incidence 73,000 with a prevalence of >500,000

• Estimated global prevalence of 2.7 million

• Following surgery, patients receive TLR4 agonist immunotherapy

with BCG

• Patients have high local recurrence rates (>50% recur within 2 years)

• Patients with BCG-refractory disease require total cystectomy and may

develop life-threatening metastases

• TLR5 is expressed in bladder and many bladder tumors, supporting

use of entolimod in BCG-refractory disease

• Cystoscopy data could provide rapid proof of concept (6-12 months)

• FDA focus on finding new bladder cancer therapies offers potential for

accelerated approval

19

Page 20: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Intravesical Entolimod Has Shown Activity in an

Orthotopic Model of Bladder Cancer

*C57BL/6 mice harboring MB49 (TLR5-negative) bladder cancer cells treated

with intravesical treatment of entolimod on Days 4 & 5 after tumor implantation

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+)

20

Tumor Size Changes

• Activation of NF-kB response in bladder epithelium

• Massive infiltration of immune cells in the tumor

• Tumor growth suppression

Extended

Survival

Page 22: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

CBLB612 Offers Opportunity as a Single-Dose

Alternative to Existing Hemopoietic Growth Factors

• Worldwide use of granulocyte colony-stimulating factor (G-CSF) (eg, filgrastim,

peg-filgrastim, lenograstim) comprises a multi-billion-dollar market in support of

chemotherapy administration

• G-CSF modestly shortens the duration of chemotherapy-related neutropenia,

does not improve thrombocytopenia or anemia, and does not provide antitumor

efficacy

• CBLB612 may offer a multilineage hematorestorative agent with the potential to

enhance antitumor efficacy through stimulation of TLR-2/6

• Could have benefits whether administered before or after chemotherapy (G-CSF only

works after chemotherapy)

• May offer improvements in neutrophil, platelet, and red blood cell counts while

mobilizing progenitor cells

• May offer antitumor effects

22

Page 23: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Dosing Was Completed in Phase 1 Healthy-Subject

Study of CBLB612 in the Russian Federation

• Randomized, placebo-controlled, dose-ranging study

• Subjects randomized 3:1 (active drug: placebo) in each cohort

• 5 cohorts evaluated at 0.5, 1, 2, 4, or 8 µg (56 subjects total)

• Results confirmed expected pharmacological profile

• Established MTD at 4 µg

• Demonstrated blood count changes (including neutrophilia)

• Documented cytokine induction

• Findings support Phase 2 evaluation of CBLB612 in a

clinical model of chemotherapy myelosuppression

23

Page 24: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Patients with metastatic

breast cancer suitable for

treatment with docetaxel

chemotherapy

A Phase 2a Study Will Evaluate CBLB612 as

Myelosuppressive Prophylaxis in Patients Receiving

Docetaxel Chemotherapy

Docetaxel chemotherapy Cycle 1, Day 0

G-CSF, 5 µg/kg

Day 1 to 14

N~13

Observation

to Day 21

Subsequent chemotherapy at investigator

discretion

CBLB612, 4 g Day 1 (post)

N~13

Observation

to Day 21

Subsequent chemotherapy at investigator

discretion

CBLB612, 4 g

Day -2 (pre)

N~13

Observation

to Day 21

Subsequent chemotherapy at investigator

discretion

Randomization to study drug (N~40)

Study Endpoints

• Depth ad duration of neutropenia, thrombocytopenia, and anemia

• Progenitor cell mobilization

• Plasma cytokines changes

• CBLB612 PK

• Safety

• Antitumor efficacy at 6 weeks

Anticipated to start in 2H2015 with partial funding

through a Russian government contract

24

Page 25: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Mobilan

Cancer Immunotherapy

25

Page 26: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Mobilan Overview

• Nonreplicating adenovirus expressing TLR5 and its agonist (secreted entolimod analog) which mobilizes immunity to the site of virus injection

• Primary indication – tumors (e.g. prostate cancer) expressing relevant viral receptor (CAR*) based on companion diagnostic test

• Proprietary IP licensed to Panacela from CBLI

* CAR = Coxsackievirus and adenovirus receptor 26

Page 27: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Proof of Principle Has Been Demonstrated in

Experimental Models

Companion diagnostic Ex vivo delivery

Mobilization of immune cells into the tumor Preclinical efficacy

Companion diagnostic Ex vivo delivery

Mobilization of immune cells into the tumor Preclinical efficacy

Companion diagnostic Ex vivo delivery

Mobilization of immune cells into the tumor Preclinical efficacy

Overexpression of CAR in

prostate cancer

• Companion diagnostic identifies overexpression of CAR in prostate cancer

• Mobilan injection stimulates immune cell infiltration

• Mobilan reduces size of prostate tumors

27

Page 28: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Mobilan Is Entering Clinical Development for

Prostate Cancer in the Russian Federation

• Multicenter, randomized, placebo-controlled, single-blinded study

• Single injection of ascending doses of Mobilan administered directly

into the prostate

• End-points:

• Primary: safety and tolerability

• Secondary: activation of anti-tumor immunity and change in PSA level

• IND opened in Russian Federation in 1Q15

• Partially funded by Russian government contract

28

Page 29: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Curaxin CBL0137 Multi-targeted Cancer Therapeutic

29

Page 30: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

CBL0137 Phase 1 Development Program Is

Progressing in Patients with Solid Tumors

Oral Administration

Russian Federation

• First-in-human, dose-ranging study

• Oral dosing schedule of CBL0137 QD x 14 days with 14 days off

• 28 patients accrued

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

• Dose escalation continuing

Intravenous Administration

United States

• Dose-ranging study

• IV dosing schedule of CBL0137 weekly x 3 weeks with 1 week off

• 26 patients accrued

• 7 dose levels evaluated (10 through 100 mg/m2/week)

• Dose escalation continuing

30

Page 31: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Observations from Both CBL0137 Studies

Support Tolerability and Potential for Activity

• No DLTs or drug-related SAEs have been observed

• Plasma pharmacokinetics indicate:

• Estimated bioavailability of >50% in oral study

• Dose-proportional increases in exposure in IV study

• Heavily pretreated patients with advanced cancers of the

esophagus, colon, liver, breast, cervix, and prostate have

had stable disease for periods ranging from 4 to 6 months

• Data support continued dose escalation toward the MTD

and advancement in Phase 2 trials

31

Page 32: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Financial Update Neil Lyons, CPA – Chief Financial Officer

32

Page 33: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Pro Forma Financial Summary (as of Dec. 31, 2014 with deconsolidation of Incuron, and Feb 2015

financing)

Cash: $13.4M

33

$s in millions (1)

CBLI &

BioLab 612

Majority-Owned

Joint Venture

(Panacela) Total

Minority-Owned

Joint Venture

(Incuron)

Cash & investments, excludes $1.7M of restricted cash $ 6.1 $ 0.5 $ 6.6 $ 1.4

Contract & grant funding available (2)

1.5 0.7 2.2 -

Contract awards, not yet funded (3)

0.7 0.7 1.4 -

Financial Partner options (4)

- 15.5 15.5 -

Total $ 8.3 $ 17.4 $ 25.7 $ 1.4

(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.

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

Page 34: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Capitalization Summary

Preferred Common Notes

Authorized shares 10,000.0 160,000,000

Preferred outstanding/common

equivalent (717.4) (239,135)

Convertible at $3/share with down-

round protection

Common, outstanding (3,435,354)

Prefunded warrants (594,688)

Convertible at $3/share with down-

round protection

Warrants, not prefunded (2,281,332) Wtd. Avg. exercise price of $14.49

Rusnano warrant (40,073)

Only exercisable upon default with

Panacela loan

Options (261,470) Wtd. Avg. exercise price of $67.89

Shares available under the EIP (262,899)

Assumes passage of 150,000

additional shares

Shares available under the ESPP (225,000)

Assumes passage of 100,000

additional shares

Available for future issuance 9,282.6 152,660,049

Securities

34

Page 35: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

• Pre-emergency-use authorization (pre-EUA) and commercialization for

Entolimod-MRC

• Pre-EUA status facilitates commercialization prior to full licensure

• On track for submission of pre-EUA to FDA in 2Q15

• Development of value-driving data and partnerships for Phase 1 oncology

drugs with novel targets and broad applications

• Entolimod-Oncology: confirm immune-stimulatory effects as a single agent or in

combination with marketed immunotherapy

• CBLB612: evaluate ability to ameliorate chemotherapy-induced myelosuppression

• Mobilan: evaluate ability to induce innate immunity in prostate cancer patients

• CBL0137: increase value as an oncology treatment by demonstrating effect in

patients with advanced disease

35

CBLI Is Focused on Achieving Strategic

Objectives

Page 36: 2015 Annual Meeting of Stockholders...filings with the Securities and Exchange Commission, including its latest Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current

Development Milestones

36

* Estimate (no PDUFA timeline) 1Additional entolimod MRC Milestones expected 2015/2016:

• DoD development contract

• Foreign Sales

2016

Q1 Q2 Q3 Q4 Q1

Entolimod - MRC1:

Pre-EUA submission X

Potential Pre-EUA Review/Feedback from FDA* X

Entolimod- Oncology:

Ph 1 advanced cancers data reported (US) X

Ph 1 advanced cancers, LPO (RF) X

Ph 1 advanced cancers data reported (RF) X

CBLB612:

Ph 1 healthy volunteer LPO (RF) X

Ph 1 healthy volunteer data reported (RF) X

Ph 2a myelosuppression prophylaxis started (RF) X

Mobilan:

Ph 1 IND open, prostate cancer (RF) X

Ph 1 prostate cancer started (RF) X

CBL0137:

Ph 1 IND open, hematological cancers X

Ph 1 oral, LPO X

Ph 1 oral, data reported X

Ph 1 i.v., LPO X

Ph 1 i.v., data reported X

2015