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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 mat29
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3. Inovio Investment Overview Leader in new vaccines and immune therapies
Differentiated product development platform
Novel synthetic immunogen design: universal protection
Superior delivery using proprietary electroporation (EP) technology
Multiple ongoing clinical trials to address cancer & infectious disease: internal development and funding through grants & partnerships
Three Phase II studies underway – interim data from two in 2012
Five Phase I studies to report data by 1H 2012
Industry-leading potency & safety
Best-in-class immune responses for cervical dysplasia & HIV
Durable immune responses
Dominant IP position for next generation vaccines/delivery system
4. Inovio’s Optimized DNA Vaccines Advantages of DNA vaccines over traditional
Harnessing the power of the body’s immune system to fight disease
Achieves the powerful immune response benefits of live virus vaccines in new diseases
Superior immune responses
No possibility of infection
All synthetic product
Improved safety profile
Potential utility to prevent & treat
Faster development
Easier to manufacture & store
fChallenge: DNA vaccines require specialized delivery to work
5. Inovio’s Solution: Optimized Delivery System
6. Inovio’s In Vivo Electroporation Delivery Efficient & effective delivery
100X increase in immune responses
Far stronger T-cell immune responses
than viral vectors
Safe and tolerable
No unwanted immune response
No residual carrier/vector causing toxicity
Optimizing devices
Delivery into muscle or skin for differentiated immune responses
Facilitate mass vaccination in the field
Broad and deep patent position
7. Inovio’s SynCon® Universal Vaccines
8. Strategic Approach Advance/validate SynCon® DNA immunogen + electroporation delivery platform
Best-in-class immunogenicity established in human studies
Increase platform value through product validation
Develop proprietary products through proof-of-concept human data
Maximize non-dilutive third party funding
Direct: R&D grants - $35M received since 2008
Indirect: Multiple ongoing clinical studies sponsored by outside agencies
Partner/out-license products for later-stage clinical development and marketing
9. Inovio Product Pipeline: Cancers
10. Inovio Product Pipeline: Infectious Diseases
11. VGX-3100: Cervical Dysplasia/Cancer Therapy Cervical cancer – 99% caused by human papillomavirus (HPV)
Second leading cancer killer in women worldwide
~500,000 new cases of cervical cancer annually
50% fatal
Gardasil® & Cervarix®
Preventive only
Far less than 100% uptake
12. VGX-3100 Therapeutic Vaccine Targets E6 + E7 oncogenes (HPV Types 16 and18)
Transform HPV-infected cells into precancerous & cancerous cells
13. VGX-3100: Phase I Study Data Strong T-cell response in 14 of 18 (78%) vaccinated subjects at month 4
12 of 13 responders (92%) displayed persistent, strong T-cell responses at month 9
After 4th vaccination, 7 of 8 (87%) displaying strong T-cell responses up to over 2 years
14. T-Cell Responses: VGX-3100 vs Other Cerv. Cancer Vaccines
15. VGX-3100: Phase II Study VGX-3100 delivered with electroporation
Randomized, blinded, placebo controlled
148 patients with CIN 2/3 (cervical dysplasia) + HPV 16/18 (cause 70% of cervical cancers)
Up to 25 sites in 5 countries
Initiated Q1 2011; enrollment ongoing
3 vaccinations over 3 months, 6 months monitoring
1°endpoint: CIN 2/3 lesion clearance at month 9
Efficacy data expected 2H 2013 Powered to detect efficacy
Study timeline
Launched 1Q 2011; enrollment underway
Enrollment: 1 – 1 ½ years
Potential extension to CIN 1; cervical cancer; other anogenital and head & neck cancers; additional HPV types
Powered to detect efficacy
Study timeline
Launched 1Q 2011; enrollment underway
Enrollment: 1 – 1 ½ years
Potential extension to CIN 1; cervical cancer; other anogenital and head & neck cancers; additional HPV types
16. Partner Vaccine Phase II: Leukemia Chronic myeloid leukemia (CML) & acute myeloid leukemia (AML): 300,000+ new cases, 222,000 deaths each year
Wilms’ tumor gene 1 (WT1)
WT1 w/o EP in humans for other cancers modest CD8+ T-cell and measurable clinical responses
Mice, with EP strong CD8+ T-cell responses; killed human tumor cells expressing WT1
Phase II open label study initiated Q1 2011
37 CML patients, 37 AML patients; 100-110 AML/CML non-vaccinated controls
1° endpoints
CML: molecular response to disease marker (BCR-ABL)
AML: time to disease progression
Interim data expected 2H 2012
222,000 deaths222,000 deaths
17. Partner Vaccine Phase II: Hepatitis C Virus CHRONVAC-C® vaccine via electroporation
Phase I outcomes: safe & well-tolerated; T-cell immune responses
Vaccination + subsequent standard of care (SOC: interferon & ribavirin):
Rapid viral response (RVR): 5 of 7 patients (71%)
Sustained viral response (SVR): 5 of 6 patients (83%)
Phase II study: open label, randomized
2 vaccinations + SOC (n=20) / SOC only (n=12)
1° endpoints
RVR (4 weeks)
Partial early viral response (pEVR) (12 weeks)
Interim data expected 1H 2012
SVR from SOC only for genotype 1 virus: typically 40-50%SVR from SOC only for genotype 1 virus: typically 40-50%
18. PENNVAX™ Global HIV Vaccine Program SynCon™ PENNVAX DNA vaccines target HIV gag, pol, and env proteins
Env protein determines subtypes (or clades)
19. PENNVAX-B: Phase I Study Interim Data Phase I study (preventive) conducted by HVTN
Randomized, placebo-controlled 3 vaccinations over 3 months
48 vaccinated subjects, 3 arms:
1 mg dose of PENNVAX-B vaccine (n=10)
1 mg dose of PENNVAX-B + IL-12 DNA (n=30)
Placebo (n=8)
Best T-cell immune responses compared to all other previously-tested HIV vaccines
Complete data: 3Q 2011
20. T-Cell Responses: PENNVAX-B vs Other HIV vaccines
21. SynCon™ Universal Influenza Vaccines
24. Financial Information
25. Investment Summary Strong management team with vast vaccine discovery & development expertise
Healthy cash position, no debt
Proven ability to secure third party grant funding
Nine clinical studies on-going, with 3 Phase IIs
Partners/collaborators funding six trials
Immune response data from five Phase I studies by 1Q 2012
Interim data from two Phase II studies in 2012