vgen investor presentation 011814-red chip

VACCINOGEN -‐ A $5+ BILLION CANCER VACCINE OPPORTUNITY

First Quarter 2014

Q1 2014 1 Stock Symbol: VGEN

A cancer vaccine company in its final stages of clinical development with a patented phase III asset -‐ OncoVAX

Stock symbol is VGEN

Vaccinogen and OncoVAX®


•  Cancer vaccine

•  Designed to reduce the risk of recurrence of cancer aLer surgery

•  Uses the paNent’s own tumor as vaccine source

OncoVAX®


Value ProposiDon


Late stage -‐ 5 clinical studies, including a staNsNcally significant phase 3 trial

$14 billion global market

$5 billion in US & Europe

Solid patent protecNon to 2025

RelaNvely simple logisNcs with few variables

Pursuing an untapped market with colon cancer

BeauNfully addresses “heterogeneity of cancer”

The results were published in the BriNsh Medical Journal The Lancet January 30, 1999; 353: 345-‐350

8701 Study -‐ Recurrence-‐Free Survival* in Stage II PaNents

OncoVAX® – Phase III(a) Clinical Results

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Treatment Control OncoVAX

0 1 2 3 4 5 6 7 8 9 10 11

Recurrence-Free Survival(No. of Recurrences or Deaths)

Population

All Patients

Stage II(Intent-to-Treat)

Stage II (Treatment Compliant)

49 (38.9%) N=126

29 (37.7%) N=77

29(37.7%) N=77

39 (30.5%) N=128

17 (21.3%)N=80

12 (19.4%) N=62

0.073

0.008

0.012

Control OncoVAX®5-yearp-value

This published, randomized Phase IIIa clinical trial was stratified by tumor stage so that a legitimate analysis by tumor stage could be calculated.These results are for Stage II colon cancer. Some benefit was seen in Stage III colon cancer however the results were not statistically significant.This study was accepted by the FDA as supportive data for the next Phase IIIb clinical trial to be conducted under an FDA granted SPA with fast track designation. The Disease-free Survival clinical endpoint will be used for the interim analysis, which is an accepted basis for FDA approval.

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OncoVAX® - Clinical Results 8701 Study - Recurrence-Free Survival* in Stage II Patients


Greatest difference between treated and control in RFI at 18 months post Vx

8701 Study -‐ Recurrence-‐Free Interval (RFI) in Stage II PaNents OncoVAX® – Phase III(a) Clinical Results

Greatest difference between treated and control in RFI at 18 months post Vx

Difference between treated and control 16.1%

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Treatment

Date run: 30NOV00

OncoVAX

0 1 2 3 4 5 6 7 8 9 10 11

Control

OncoVAX® - Clinical Results 8701 Study - Recurrence-Free Interval (RFI) in Stage II Patients


•  751 paNents treated over five studies

•  Phase III trial showed 61% improvement of survival

•  Non treated group – 1/3 of paNents recurred (as stage 4)

•  OncoVAX treated group – only 1/10 recurred

Clinical history & foundaDon for OncoVAX®


310,000 total cases of stage II & III colon cancer in Western

world

Target market


IniDal targets Annual cases in Western markets

Stage II colon cancer 160,000

Stage III colon cancer 150,000

Key consideraDons

Item Key benefits

Acceptable price per vaccine $54,000 -‐ $70,000

Internal cost per vaccine $7,000 -‐ $8,000

US & Europe market -‐ stage 2 & stage 3 colon cancer

300,000 cases per year

Likely market penetraNon 30% to 55%

Asian colon cancer market potenNal 200,000 cases per year

Other potenNal targets Renal cancer, melanoma, ovarian cancer, non small-‐cell lung cancer

Scale? Yes – all process are the same across all indicaNons


Revenue scenarios on just colon cancer @ $55,000


PenetraDon (Western Market)

Vaccines sold Revenues

10% 31,000 $1.7 billion

20% 62,000 $3.4 billion

30% 93,000 $5.1 billion

40% 124,000 $6.8 billion

50% 155,000 $8.5 billion

60% 186,000 10.2 billion

Patent coverage

•  Sterility Patent – covers the sterile manufacturing process –  Expires 2025 –  Approved in all major markets

•  Two other patents being filed currently


Vaccine Manufacturing

On the 3rd and 4th injecNon, the immune system reacts!

3 part process After injection:

Immune responds by killing all leftover live tumor cells

Step 1

• 3 grams of live tumor cells removed at surgery and shipped to VGEN

Step 2 • VGEN makes cells into a sterile, “safe vaccine – OncoVAX”

Step 3

• 30-‐35 days later, VGEN ships OncoVAX back to the hospital for final compounding and injecNon

PaNent’s own tumor cells re-‐injected 4 Nmes in the skin


LogisDcs = How we “de-‐risk” this investment


Vaccine Material PaDent’s own tumor

Transport of Nssue to VGEN Via transplant courier

Hands on manufacturing Nme 6 hours

Transport of finished vaccine Frozen via Fed Ex

AdministraNon of vaccine Intradermal injecNon

Internal costs per vaccine $7,000 to $8,000

Colon Cancer today – sDll an untapped market

Stage II colon cancer

Stage III colon cancer

% of all colon cancers

40% 37%

Current treatment Surgery only Surgery + chemotherapy

Recurrence rate 1/3 1/2

Survival rate if cancer returns

<6% (now stage 4) <6% (now stage 4)


Heterogeneity within primary tumors

Yachida, et al., Nature 467: 114, 2010.!

Q1 2014 Stock Symbol: VGEN 15

Coming up -‐ Pivotal, Confirmatory Phase III (b)

•  550 paNent phase III trial – confirmatory

– SPA and Fast Track

•  Parallel phase I/II study for stage III colon cancer


Management


Michael G. Hanna Jr., Ph.D. CEO, Chairman inventor

Andrew L. Tussing President COO

Debra Hoopes Chief Financial Adviser

John Powers OperaNons -‐ LogisNcs

Dinand Van der Linde Head of Europe

Herbert C. Hoover, MD Chief Medical Adviser

Medical Advisory Board Michael G. Hanna, Jr., Ph.D. Immunology Invent of OncoVAX® NaNonal

Cancer InsNtute, authored 225 publicaNons

John S. Macdonald, MD Specialist in GastrointesNnal Cancer

Harvard, B. Israel, Georgetown, New York Medical. College

Benjamin S. Carson, MD Neurosurgery Johns Hopkins, PresidenNal Medal of Freedom, authored 100+ publicaNons, 4 books

H.C. Hoover, MD Surgical Oncology Johns Hopkins, Harvard, inolved in all 5 OncoVAX studies

Jan Vermorken, MD, Ph.D. Oncology University of Antwerp, Vrije, principal invesNgator in previous 8701 phase III OncoVAX trial


Summary – De-‐risking aspects of this investment

Q1 2014 19

•  Public company – fully reporNng •  Phase III results in hand •  LogisNcs – proven, stable and scalable •  Clear path ahead in colon cancer •  ShiLing standard of care from surgery alone

•  85% margins on a mulN-‐billion market

Stock Symbol: VGEN

Contact:

Q1 2014 20

•  Andrew L. Tussing, President & COO •  [email protected]

•  (US) 301 668-‐8400

Stock Symbol: VGEN

Forward Looking Statements This presentaNon and related commentary may contain forward-‐looking statements within the meaning of the SecuriNes Act of 1933 (the “Securi(es Act”) and the SecuriNes Exchange Act of 1934 (the “Exchange Act”) and are subject to the safe harbor created by the Private SecuriNes LiNgaNon Reform Act of 1995. Vaccinogen has based these forward-‐looking statements largely on our expectaNons and projecNons about future events and financial trends affecNng the financial condiNon and/or operaNng results of its business. Forward-‐looking statements involve risks and uncertainNes; parNcularly those risks and uncertainNes inherent in the process of discovering, developing and commercializing drugs that are safe and effecNve for use as human therapeuNcs. There are important factors that could cause actual results to be substanNally different from the results expressed or implied by these forward-‐looking statements, including, among other things: • Vaccinogen’s ability to successfully manufacture OncoVAX® and other product candidates in necessary quanNNes with required quality; • Vaccinogen’s ability to successfully obtain regulatory approvals and commercialize its products that are under development and develop the infrastructure necessary to support commercializaNon if regulatory approvals are received; • Vaccinogen’sability to complete and achieve posiNve results in ongoing and new clinical trials; • Vaccinogen’s dependence on single-‐source vendors for some of the components used in its product candidates; • the extent to which the costs of any products that Vaccinogen is able to commercialize will be reimbursable by third-‐party payers; • the extent to which any products that we are able to commercialize will be accepted by the market; • Vaccinogen’s dependence on our intellectual property and ability to protect its proprietary rights and operate its business without conflicNng with the rights of others; • the effect that any intellectual property liNgaNon, or product liability claims may have on Vaccinogen’s business and operaNng and financial performance; • Vaccinogen’s expectaNons and esNmates concerning its future operaNng and financial performance; • the impact of compeNNon and regulatory requirements and technological change on Vaccinogen’sbusiness; • Vaccinogen’s ability to recruit and retain key personnel; • Vaccinogen’s ability to enter into future collaboraNon agreements; and • anNcipated trends in our business and the biotechnology industry generally\ In addiNon, in this presentaNon and related commentary, the words “believe,” “may,” “will,” “esNmate,” “conNnue,” “anNcipate,” “intend,” “plan,” “expect,” “potenNal,” or “opportunity,” the negaNve of these words or similar expressions, as they relate to Vaccinogen, its business, future financial or operaNng performance or Vaccinogen’s management, are intended to idenNfy forward-‐looking statements. Past financial or operaNng performance is not necessarily a reliable indicator of future performance and you should not use Vaccinogen’s historical performance to anNcipate results or future period trends. Because such statements involve risks and uncertainNes, many of which are outside of Vaccinogen’s control, Vaccinogen's actual results and performance may differ materially from the results expressed or implied by such forward-‐looking statements. Given these risks and uncertainNes, readers are cauNoned not to place undue reliance on such forward-‐looking statements. Other important risk factors that may affect Vaccinogen's business, results of operaNons and financial posiNon are discussed in its most recently filed RegistraNon Statement on Form 10 and in other SecuriNes and Exchange Commission filings. Unless otherwise required by law, Vaccinogen also disclaims any obligaNon to update its view of any such risks or uncertainNes or to announce publicly the result of any revisions to the forward-‐looking statements made here. However, readers should review carefully reports and documents that Vaccinogen files periodically with the SecuriNes and Exchange Commission.


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