23
Page 1 J. Joseph Kim, Ph.D. President & CEO

Inovio Pharmaceuticals 2012 Investor Presentation

Embed Size (px)

Citation preview

Page 1: Inovio Pharmaceuticals 2012 Investor Presentation

Page 1

J. Joseph Kim, Ph.D.

President & CEO

Page 2: Inovio Pharmaceuticals 2012 Investor Presentation

Page 2

Forward Looking Statement

Our commentary and responses to your questions may contain forward-looking

statements, including comments concerning clinical trials and product

development programs, evaluation of potential opportunities, the level of

corporate expenditures, the assessment of Inovio’s technology by potential

corporate partners, capital market conditions, timing of events, cash

consumption and other subjects. Information concerning factors that could

cause actual results to differ materially from those set forth in our Annual

Report on Form 10-K for the year ended December 31, 2011, our Form 10-Q

for the quarter ended June 30, 2012, and other regulatory filings from time to

time.

Page 3: Inovio Pharmaceuticals 2012 Investor Presentation

Page 3

• Inovio’s synthetic vaccine technology designed to:

• Treat some of today’s most challenging diseases

• Universally protect against changing infectious disease strains

• Break the body’s tolerance of cancerous cells

• Targeting unmet needs with multi-billion dollar potential:

cancers, universal flu, HIV, hepatitis B/C virus

• Multiple ongoing clinical trials: phase II and phase I

• Industry-leading potency & safety

• Best-in-class immune responses for cervical dysplasia & HIV

• Dominant global IP position (424 patents issued/pending)

• Validation:

• $35M+ in non-dilutive grant funding over last few years

• Advancing discussions for vaccine product development

partnerships and further grant funding

Inovio: Revolutionizing Vaccines

Page 4: Inovio Pharmaceuticals 2012 Investor Presentation

Page 4

Conventional Vaccines

• Saved millions from sickness/death

• Added decades to life expectancy

• Deliver a virus or part of a virus to

expose a unique antigen (foreign

protein)

• Generate antibodies that prevent

targeted diseases from infecting cells

• Low hanging fruit picked – old

technology has reached its limitations

• Safety concerns: can cause the

disease or other bad side effects

• Rely on technology that is often more

than 50 years old; some vaccines are

still grown in chicken eggs

Increased life expectancy

Five decade-old technology is great . . .

but does not solve tomorrow’s challenges

Page 5: Inovio Pharmaceuticals 2012 Investor Presentation

Page 5

Synthetic DNA Vaccine Platform

Revolutionizing vaccines through: • Strong safety profile

• SynCon® “designer vaccines” give the body the DNA instructions to produce only the

targeted antigen - nothing more

• Generate powerful T-cells to kill infected cells or tumors (therapeutic vaccines)

• Manufacturing advantages: rapid, scalable, thermal-stable

Page 6: Inovio Pharmaceuticals 2012 Investor Presentation

Page 6

SynCon® Universal Vaccine Design

Immune responses more cross-reactive (universal)

than those induced by single-strain vaccines

Page 7: Inovio Pharmaceuticals 2012 Investor Presentation

Page 7

Superior Vaccine Delivery Using Electroporation

> 10-100x enhancement in immune responses

Page 8: Inovio Pharmaceuticals 2012 Investor Presentation

Page 8

Best-in-Class Immune Responses in Humans

Inovio Clinical

Study

Clinical

Results

Competition

FLU-001/002

H5N1

Pandemic Flu

Broad

protective

antibody

titers against

6 different

H5N1 strains

Stockpiled

inactivated

vaccines

FLU-101

Universal Flu –

H1N1

Broad

protective

antibody

titers against

9 different

H1N1 strains

Trivalent

inactivated

virus vaccines

(TIV)

Live-attenuated

vaccines

Inovio Clinical

Study

Clinical Results Competition

HPV-001

Cervical

Cancer/

Dysplasia

Best in class T

cell responses

(magnitude and

durability)

Adenovirus vectors

MVA vectors

DNA vaccines

Peptides/proteins

HVTN-080

Preventive HIV

Vaccine

Best in class T

cell responses

(magnitude and

durability)

Adenovirus vectors

MVA vectors

DNA vaccines

Peptides/proteins

Combinations

Immune Responses

T Cell Responses Antibody Responses

Page 9: Inovio Pharmaceuticals 2012 Investor Presentation

Page 9

Inovio’s Strategy

• Advance/validate SynCon® + electroporation platform

• Best in-class immunogenicity established in human studies

• Develop proprietary products through proof-of-concept

human data (phase I or phase II)

• Maximize resources/opportunities; spread cost/risk

• Non-dilutive third party funding

• Direct: R&D grants

– $35M received since 2008

• Indirect: clinical trials sponsored by outside agencies

– Seven ongoing studies

• Partner/out-license product for preclinical/clinical

development and marketing

Page 10: Inovio Pharmaceuticals 2012 Investor Presentation

Page 10

Inovio Product Pipeline: Cancers

Indication Product (Antigen) Pre-

clinical Phase I Phase II Partner/Funding Milestone

Cancers

Cervical Dysplasia

Therapeutic

VGX-3100 (E6/E7

Type 16/18 HPV)

2H 2013

Phase II study data

Leukemia (Wilms’ tumor

gene 1)

University of

Southampton

4Q 2012

Interim Phase II data

Prostate INO-5150

(PSA + PSMA)

1H 2013

Initiate Phase I

Breast/Lung/

Prostate

V934

(hTERT) Merck

Internally Funded

Partner Funded/Supported

Page 11: Inovio Pharmaceuticals 2012 Investor Presentation

Page 11

Inovio Product Pipeline: Infectious Diseases

Indication Product (Antigen) Pre-

clinical Phase I Phase II Partner/Funding Milestone

Infe

cti

ous

Dis

ease

s

Hepatitis C Virus

Therapy

(NS3/4A) + SOC ChronTech 4Q 2012

Phase II interim data

INO-8000 (NS3/4A, NS4B, NS5A)

PA CARE Grant/

VGX Inter

2H 2013

Initiate Phase I

HIV Preventive

PENNVAX-B HIV Vaccine

Trials Network

Phase I final data

submitted for

publication

PENNVAX-G USMHRP/NIAID 1H 2013 Additional

Phase I data

PENNVAX-GP NIH/NIAID 1Q 2013

Initiate Phase I

HIV Therapeutic PENNVAX-B University of

Pennsylvania

4Q 2012

Final Phase I data

Pandemic Influenza

-Avian (H5N1) VGX-3400X

Manuscript in

preparation

Universal Influenza –

Healthy Adults INO-3510

NIH Transformative

Research Award

1Q 2013

Add’l Phase I data

Universal Influenza –

(H1N1) in Elderlies FVH1

U. of Manitoba/

Canadian Institute of

Health Research

1Q 2013

Interim Phase I data

Internally Funded

Partner Funded/Supported

Page 12: Inovio Pharmaceuticals 2012 Investor Presentation

Page 12

VGX-3100: Cervical Dysplasia/Cancer Therapy

• Cervical cancer: ~500,000 cases, 250,000 deaths yearly

• Cervical dysplasias (CIN) preceding cancer (U.S. annually)

• CIN 1: 1.4 M ; CIN 2/3: 300,000

• VGX-3100 phase I

• 18 patients, 3 dose levels

• Vaccine safe and well-tolerated

• Most robust T-cells generated by

a DNA vaccine in humans

• Stronger responses than other

vaccines, including viral vectors

• Strong T-cell response in 14 of 18

(78%) vaccinated subjects at month 4

• Durable responses: 12 of 13 responders (92%) displayed

persistent, strong T-cell responses at month 9

Low Mid High All

Dose Level

T cell

responses

by other

vaccines

Page 13: Inovio Pharmaceuticals 2012 Investor Presentation

Page 13

VGX-3100: Phase II Study

• Randomized, blinded, placebo controlled

• > 25 sites in multiple countries

• 148 patients with CIN 2/3

• Three vaccinations over 3 months, 6 months monitoring

• Primary endpoint: CIN 2/3 lesion clearance at month 9

• Initiated in 2011; enrollment ongoing

• Efficacy data expected 2H 2013

Page 14: Inovio Pharmaceuticals 2012 Investor Presentation

Page 14

• Chronic myeloid leukemia (CML)

• Acute myeloid leukemia (AML)

• Vaccine coded for Wilms’ tumor gene 1 (WT1)

• Overexpressed in majority of acute leukemias

• Open label phase II clinical trial

• Active: 37 CML patients, 37 AML patients

• Control group: 100-110 AML/CML patients, non-vaccinated

• Primary endpoints

• CML: molecular response to disease marker (BCR-ABL)

• AML: time to disease progression

• Initiated in 2011; enrollment ongoing; interim data expected 4Q 2012

300,000+ new cases,

222,000 deaths yearly

Leukemia Vaccine: Phase II

Page 15: Inovio Pharmaceuticals 2012 Investor Presentation

Page 15

ChronVac-C® Therapeutic Vaccine

• Hepatitis C virus (HCV)

• 3.5 million chronically infected in US; >170 million worldwide

• Causes liver disease/cancer

• Positive phase I study (HCV genotype 1): ChronVac-C + standard of care (SOC:

interferon & ribavirin)

• Safe & well-tolerated

• Positive T-cell immune responses

• Sustained viral response (SVR): 5 of 6 patients (83%)

• Open label, randomized phase II study (32 patients)

• Vaccinated (20): 2 vaccinations; Control (12): SOC only

• Primary endpoints

• Rapid viral response (4 weeks)

• Partial early viral response (pEVR) (12 weeks)

• Initiated in 2011; enrollment ongoing

• Interim data expected 4Q 2012

Page 16: Inovio Pharmaceuticals 2012 Investor Presentation

Page 16

PENNVAX-B: Phase I Studies

• Preventive study, randomized, placebo-controlled: run by HVTN

• Three vaccinations over 3 months; 48 vaccinated subjects, 3 arms: • 1 mg PENNVAX-B (n=10)

• 1 mg PENNVAX-B + DNA IL-12 delivered via EP (n=30)

• Placebo (n=8)

• T-cell immune responses superior to all other previously-tested HIV vaccines

• Submitted for publication

__________________________________________________________________

__________________________________________________________________

• Therapeutic study, open label, 12 vaccinated subjects, run by UPenn

• Significant antigen-specific CD8+ T-cell responses:

• against at least 1 of 3 antigens (gag, pol, or env) in 75% of subjects

T-cell Responses by intracellular cytokine staining (ICS) assay

Positive Reponses Placebo Group Vaccine + DNA IL-12 + EP

Total CD4 + CD8 0% (0/8) 88.9% (24/27)

Page 17: Inovio Pharmaceuticals 2012 Investor Presentation

Page 17

SynCon® Universal Influenza Vaccines

Potential to shift flu vaccination

from “one bug, one drug” approach to

pre-emptive, universal prevention across

strains, subtypes and years

• H5N1 phase I data:

• Strong T-cell/antibody responses

• => 1:20 HAI titers – 71% positive

responders to at least 1 H5N1 virus

• Protection against all six

unmatched H5N1 strains tested

• H1N1 phase I data:

• Significant # of responders

exceeding 1:40 HAI titers against

different strains

• Protection against all nine

unmatched H1N1 strains tested

Page 18: Inovio Pharmaceuticals 2012 Investor Presentation

Page 18

Management

J. Joseph Kim, Ph.D., President &

CEO

• Decades of biotechnology/pharma

management

• Ex-Merck: hepatitis A and B vaccines

manufacturing; HIV vaccine (Ad5)

R&D

Peter Kies, CFO

• Ex-Ernst & Young

• Experience with growth companies

Niranjan Y. Sardesai, Ph.D., COO

• Extensive biotech management

and product development

experience

• Led development of diagnostics

for mesothelioma, bladder

cancer, and ovarian cancer for

Fujirebio Diagnostics

Mark L. Bagarazzi, M.D., CMO

• Clinical research experience incl.

Merck

• Led clinical/regulatory for shingles

and rotavirus vaccines; DNA vaccine

expert

Managed development and approval of several vaccines

Page 19: Inovio Pharmaceuticals 2012 Investor Presentation

Page 19

Board of Directors

Avtar Dhillon, M.D., Chairman, BOD

• Former President & CEO, Inovio

Biomedical

Morton Collins, Ph.D.

• General Partner, Battelle Ventures

and Innovations Valley Partners

Simon X. Benito

• Former Senior Vice President, Merck

Vaccine Division

J. Joseph Kim, Ph.D.

• President & CEO, Inovio

Angel Cabrera, Ph.D.

• President, George Mason University

• Former President, Thunderbird School

of Global Management

Adel Mahmoud, Ph.D.

• Professor, Princeton University

• Former President, Merck Vaccines

• Responsible for Gardasil®, Zostavax®,

Proquad® and Rotateq®

Page 20: Inovio Pharmaceuticals 2012 Investor Presentation

Page 20

Scientific Advisory Board

David B. Weiner, Ph.D., Chairman, SAB

• “Father of DNA vaccines”

• Dept. of Pathology & Laboratory

Medicine, U of PA

Thomas S. Edgington, M.D.

• Founded multiple biotech companies;

extensively published

• Emeritus Professor, Scripps Research

Institute

Philip Greenberg, M.D.

• Expert in T-cell immunology

• Head, Immunology Program, Fred

Hutchinson Cancer Research Center

Anthony W. Ford-Hutchinson, Ph.D.

• Former SVP, Vaccines R&D, Merck

• Oversaw development: Singulair®,

Januvia®, Gardasil®, Zostavax®,

Proquad® and Rotateq®

Stanley A. Plotkin, M.D.

• Developed rubella and rabies vaccines

• Oversaw Sanofi flu vaccine

• Emeritus Professor, Wistar Institute &

U of Penn

Page 21: Inovio Pharmaceuticals 2012 Investor Presentation

Page 21

Financial Information

Cash & short term investments1 $19.5 M

Debt1 0 M

Burn rate ~$4.5 M/Q

Cash runway 3Q 2013

Listing NYSE MKT: INO

Issued & outstanding shares1 134.9 M

Recent price2 $0.63

Market cap2 $85 M

1 June 30, 2012 2 September 18, 2012

Page 22: Inovio Pharmaceuticals 2012 Investor Presentation

Page 22

Investment Summary

• Paradigm shifting synthetic vaccine platform displaying best-in-

class immunogenicity and other characteristics significantly

improving upon conventional and new competitive vaccine

technologies

• Strong management team with vast vaccine discovery &

development expertise

• Extensive third-party grant funding

• Important validating clinical milestones over next quarters

• Advancing discussions with large pharmaceutical

companies with the goal of securing new partnerships to

advance development and commercialization of SynCon®

vaccines

Page 23: Inovio Pharmaceuticals 2012 Investor Presentation

r e v o l u t i o n i z i n g v a c c i n e s

Investor Contact:

Bernie Hertel

Senior Director, Corporate Communications

858-410-3101 ● [email protected]

NYSE MKT: INO www.inovio.com