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| 8-K - FORM 8-K - BIOVEST INTERNATIONAL INC | d8k.htm |
 Fighting Lymphoma, and Making it Personal.
Carlos F. Santos, Ph.D.
Senior Vice President,
Scientific/Regulatory Affairs &
Product Development
www.biovest.com
OTCQB: “BVTI”
ROTH Capital OC Growth Stock Conference
Monday, March 14
th
, 2011 |
 Safe
Harbor Statement Statements
in
this
presentation
that
are
not
strictly
historical
in
nature
constitute
"forward-
looking statements." Such statements include, but are not limited to statements
about BiovaxID®, AutovaxID™, events occurring after dates hereof,
and any other statements relating to products, product candidates, product
development programs, the FDA or clinical study
process
including
the
commencement,
process,
or
completion
of
clinical
trials
or
the
regulatory process. Such statements may include, without limitation, statements
with respect to
the
Company's
plans,
objectives,
expectations
and
intentions,
and
other
statements
identified by words such as "may," "could," "would,"
"should," "believes," "expects,"
"anticipates," "estimates," "intends," "plans," or
similar expressions. Such forward-looking statements involve known
and unknown risks, uncertainties, and other factors that may cause the
actual results of Biovest to be materially different from historical results or from
any results expressed or implied by such forward-looking statements. These
factors include, but are not limited to, risks and uncertainties related to
the progress, timing, cost, and results of clinical trials and product
development programs; difficulties or delays in obtaining regulatory
approval for product candidates; competition from other pharmaceutical or
biotechnology companies; and the additional risks discussed in filings with the
Securities and Exchange Commission. All forward-looking statements are
qualified in their entirety by this cautionary statement, and Biovest
undertakes no obligation to revise or update this presentation to reflect
events or circumstances after the date hereof. The product names used
in
this
statement
are
for
identification
purposes
only.
All
trademarks
and
registered
trademarks are the property of their respective owners.
|
 Exchange/Ticker:
OTCQB: BVTI
Price per share:
$0.62
Market Cap:
$87 million
52-week Range:
Low $0.59 / High $2.05
Shares Outstanding:
140.2M shares
Float:
49.2 million shares**
Avg. Daily Volume:
149,000 shares
Biovest Market Data*
* Market data as of
3/11/11
** Accentia
Biopharmaceuticals,
Inc,.
(OTCQB:
ABPI)
owns
approx.
91M
shares |
 Overview
•
Dendreon’s Provenge approval in April 2010 represents first
successful therapeutic cancer vaccine (positive results + approval)
•
BiovaxID Phase 3 trial represents landmark in lymphoma for
vaccines (1
st
vaccine to show DFS benefit in Phase 3)
•
Therapeutic vaccines are extremely safe, focus powerful immune
response against tumor cells to alter the natural progression of
cancer.
•
BiovaxID proves the hypothesis for cancer vaccines
•
Multiple cancer vaccines in development representing multi-billion
dollar market opportunity with only one successful Phase 3 in NHL
(BiovaxID)
Therapeutic Cancer Vaccines |
 BiovaxID
Investment Highlights •
1
st
proven
clinically
effective
vaccine
for
Non-Hodgkin’s
Lymphoma
•
Potentially 2
nd
approved cancer vaccine in the world
•
Completed Phase 3 clinical trial: BiovaxID extends disease-free survival in
FL (Schuster, et al. ASCO 2009 and ASH 2010)
•
No vaccine attributable SAE’s in Phase 3 and Phase 2 studies
•
IgM-Id delivers 2+ years of complete remission in NHL vaccinated patients
and is fundamental discovery for next-generation vaccines.
|
 Company
Product
Indication
Phase I
Phase 2
Phase 3
Marketed
Dendreon
Provenge
Prostate
Biovest
BiovaxID
fNHL
Menarini
Abagovomab
Ovarian
Oncothyreon/
Merck KGaA
Stimuvax
NCSLC
GSK
MAGE-A3
NSCLC
Vical
Allovectin-7
Melanoma
Bavarian Nordic
Prostvac
Prostate
New Link
HyperAcute
Pancreatic
Celldex
Rindopepimut
Glioblastoma
Geron
GRNVAC1
AML
TVAX
TVI
Astrocytoma
Prima
Cvac
Ovarian
Oxford Biomedica
TroVax
Prostate
Argos
AGS-003
Renal Cell
Cancer Vaccines in Phase 2/3 Clinical Trials |
 Approx
140,000 pt’s diagnosed in US* and EU** Est. 50,000 men and women will
die of NHL in 2010 in US* and EU**
Median age at diagnosis for non-Hodgkin lymphoma was
67 years of age in US*
Based on rates from 2005-2007, 2.10% of men and
women born today will be diagnosed with NHL in their life*
In US, approximately 438,325 patients have a history of
non-Hodgkin lymphoma (similar rates in EU)*
7
Follicular and Mantle Cell Lymphoma
*Source: NCI SEER Stat Fact Sheets: Non-Hodgkin
Lymphomahttp://seer.cancer.gov/statfacts/html/nhl.html **Source: European
Cancer Observatory (http://eu-cancer.iarc.fr/2-cancer-fact-sheets.html,en)
Multi-Billion Global Market Opportunity |
 BiovaxID
Vaccine Manufacture |
 Hybridoma
Autologous Production Process Preserves Isotype
Hollow-Fiber Bioreactor
Cultures Tumor Derived Cells
(Heterohybridoma)
for Id Protein Production
Isotype-Matched Id Protein
Secreted and
Purified |
 |
 Phase 3 Id Vaccine Studies by Isotype
Phase 3 Study
Vaccine Isotype
Genitope
MyVax
®
IgG
Favrille
SpecifId
®
IgG
Biovest
BiovaxID
®
IgG
IgM
No
Benefit
Clinical
Benefit |
 Median Follow-up
56.6 mo (range 12.6 –
89.3)
Median DFS
Id-vaccine = 44.2 mo
Control = 30.6 mo
N = 117
Id-vaccine N = 76
Control N = 41
Events
Id-vaccine = 44
Control = 29
Cox PH Model
HR = 0.62; [95% CI:
0.39,0.99] (p=0.047)
log-rank
p=0.045
Control arm
Id-vaccine arm
Modified ITT Disease Free Survival from Randomization:
Id-vaccine vs. Control (n=117) |
 Disease Free Survival for Patients with IgM-isotype lymphomas:
IgG-Id Vaccine vs. Control Vaccine
Median Follow-up
56.6
mo
(range
12.6
–
89.3)
Median DFS
IgG-Id vaccine
35.1 mo [95% CI: 26.7,64]
Control
32.4 mo [95% CI:26.7,NA]
N = 55
IgG-Id vaccine N = 40
Control
N = 15
Events
IgG-Id vaccine = 26
Control = 8 |
 Disease Free Survival for Patients with IgM-isotype lymphomas:
IgM-Id Vaccine vs. Control Vaccine
Median Follow-up
56.6
mo
(range
12.6
–
89.3)
Median DFS
IgM-Id vaccine =
52.9 mo [95% CI:40.2,NA
Control =
28.7 mo [95% CI:21.0,39.8]
N = 60
IgM-Id vaccine N = 35
Control
N = 25
Events
IgM-Id vaccine = 17
Control = 20 |
 Disease Free Survival for Patients receiving IgM-Id or IgG-Id
Vaccine vs. All Patients Receiving Control Vaccine
IgM-Id Vaccine
IgG-Id Vaccine
All Controls
Median Follow-up
56.6 mo (range 12.6 –
89.3)
N = 115
IgG-Id vaccine N = 40
IgM-Id vaccine N = 35
Control N = 40
IgM-Id Vaccine vs All
Controls:
p=0.01
IgG-Id Vaccine vs All
Controls:
p=0.30 |
 Expected Key Milestones: BiovaxID
•
Publish Phase III BiovaxID follicular lymphoma
results in leading
cancer peer-review journal (includes IgM data) •
Report additional BiovaxID Phase III data to support regulatory filings,
including immune response data (a secondary endpoint) with analysis
ongoing at MD Anderson Cancer Center
•
Accelerate the advancement of BiovaxID through strategic
partnership(s)
•
Meet with FDA and other international regulatory agencies to
determine regulatory pathway in seeking
approval(s)
•
Announce new clinical trials targeting indications such as: mantle cell
lymphoma; FL in Rituximab refractory
settings;
and FL during “watchful wait”
•
Conduct ribbon-cutting event to open Minneapolis Cell Culture Center
BiovaxID facility (funded via State/City private/public partnership)
|
 Expected Key Milestones: Cell Culture
•
Report next series of results from Naval Health Research
Center viral growth studies (H1N1) in hollow-fiber bioreactor
and publish results in peer-review journal
•
Announce strategic collaborations including new bioreactor
CRADA contract with U.S. Government, Department of
Defense (development and revenue-generating event)
•
Report multiple new revenue-generating manufacturing
contracts for biologics production (MN Cell Culture Center)
•
Secure new U.S. and foreign distribution agreement(s) with
bio-instruments leader(s) to market Biovest’s line of hollow-
fiber bioreactors |
 Expected Key Milestones: General Corporate
•
Secure additional equity research analyst coverage from
respected investment banking firm(s)
•
Elevate stock listing to OTCQX Market, the highest market
tier of the Over-the-Counter Market
•
Announce formation of Scientific Advisory Board consisting
of key opinions leaders in cancer vaccine field
•
Advance our proactive investor relations and public relations
campaign to raise awareness and highlight achievement of
key milestones, including attending/presenting at key
investment and scientific conferences
•
Continue to file new patent applications (biologics &
instruments)
•
Actively support lymphoma patient advocacy efforts |
 Contact
Biovest For more
information,
please contact:
Douglas W. Calder
Director, Vice
President
Strategic Planning & Capital Markets
324 S. Hyde Park Avenue; Suite 350
Tampa, Florida, 33606, USA
Phone: 813-864-2558
Email: dwcalder@biovest.com |