EX-99.1 2 dex991.htm POWERPOINT PRESENTATION Powerpoint Presentation
1
EXHIBIT 99.1


2
FORWARD LOOKING STATEMENTS
Statements in this
PowerPoint presentation
that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but are not limited to,
statements about BiovaxID and AutovaxID-C and any other statements relating to
Biovest's products, product candidates, and product development programs. Such
statement 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
Biovest's actual results 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 Biovest's 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
Biovest's 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 PowerPoint presentation to reflect
events or circumstances after the date hereof.


3
Biovest: Corporate Overview
Company
Strong
foundation
in
the
GMP
manufacture
of
biologics
and
nearly
two decades
of experience in automated cell culture instrumentation.
Designated by the NIH as National Cell Culture Center for over 10 years.
Products
Opportunity
Revenue from sale of AutovaxID-C instruments in 2007
Revenue from commercial launch of BiovaxID potentially as early as 2009
Lead product target to treat 34,000 new indolent follicular  B
cell lymphoma patients per year
164,000 new patients with B cell non-Hodgkin’s lymphoma
and related diseases each year worldwide
Only therapy shown in peer reviewed publication to induce
both clinical and molecular remission in patients with follicular
lymphoma
Only therapy for follicular lymphoma being developed in
collaboration with the National Cancer Institute
Only autologous immunotherapy containing complete copy of
a patient’s own target protein.
Proprietary instruments offer technological and
economic advantages to Biovest
Believed to be the only scalable automated
manufacturing technology for personalized biologics
available today
Supports world-wide roll-out of Biovest personalized
medicine products
Positions Biovest to capitalize on the expected growth in
personalized medicine
BiovaxID
AutovaxID-C


4
Biovest Management Team
Former Vice President and Manager, Worldwide Marketing and Sales
for Bio-Rad Laboratories
Former Vice President and General Manager, Waters Corp.
James Carroll
General Manager, Advanced
Instrumentation Division
Over 20 years with Biovest in key scientific roles
Recipient of NIH National Cell Culture Grant for over 15 years
Recognized expert in automated cell culture methodology
Mark Hirschel, Ph.D.
Chief Scientific Officer
CFO for life science companies
Extensive background in public and private accounting, GAAP
accounting principles, SEC reporting requirements, Sarbanes Oxley
compliance
Jim McNulty, CPA
Chief Financial Officer
Over 25 years experience managing R&D organizations
Former VP R&D Creative BioMolecules, an early leader in biological
therapeutics
Carl M. Cohen, Ph.D.
Chief Operating Officer
President of The Center of Health Outcomes and Economics       
at Bristol Meyers Squibb
Faculty positions at Columbia University, University of Toronto
and
the University of Kentucky
President and COO, Accentia Biopharmaceuticals
Steve Arikian, M.D.
Chairman of the Board, CEO
Experience
Name


5
Biovest: Cutting Edge Therapeutics & Advanced Instrumentation
BiovaxID: In
development
for
treatment
of indolent
follicular lymphoma, a type of non-Hodgkin’s lymphoma
(NHL)
NHLs: fifth leading cause of cancer death in the US 
85-90% are of B-cell origin –
target of BiovaxID
164,000 new cases  of B cell NHL and related diseases
per year worldwide
Incidence of NHL is increasing 4% per year
80% increase between 1973 and 1997
Therapeutics
AutovaxID-C:
Advanced instrumentation for commercial
production of biological therapies
Provides economic advantage to Biovest in the cost
effective manufacture of BiovaxID
Revenues from sale of AutovaxID-C projected fiscal 07
Key enabling technology for personalized medicines
Market expected to grow rapidly with trend to
personalized medicines.
Advanced
Instrumentation


6
BiovaxID


7
B cell lymphomas and related diseases:  164,000 new cases per year
52,000
15,500
19,000
17,500
4) Multiple Myeloma
163,650
63,600
13,750
34,300
Tot
37,700
12,600
2,800
6,800
ROW
57,300
68,650
Total
3) Aggressive NHLs
(e.g. Diffuse; Mantle-cell; Mediastinal
large-cell; Lymphoblastic; Burkitt-like;
Burkitt’s lymphoma)
2) Indolent NHLs –
Other subtypes
(e.g., MALT; Nodal; Small lymphocytic)
1) Indolent Follicular NHL
Disease or category
22,000
29,000
4,800
6,150
11,500
16,000
Europe
North
America
Estimated new cases per year
1:ROW: Rest of World
Note: Numbers reflect rounding.
Data for North-America covers US and Canada; Europe cover France, Germany, Italy, Spain, and the United Kingdom;
Sources:
National
Cancer
Institute,
1999;
Datamonitor
OncoVision
v3.0
This is the
indication being
investigated in
the current trial
This is the
indication being
investigated in
the current trial
1


8
Source:
Redbook,
IMS
health,
ING
April
2005;
Companies’
websites
Nov. 2005
05/2002
12/1997
10/1998
02/2004
03/2004
Launch Date (US)
$260.8
$121,000
monoclonal
antibody
Metastatic
Colorectal
Erbitux
®
$479.0
$64,000
monoclonal
antibody
Breast Cancer
Herceptin
®
monoclonal
antibody
monoclonal
antibody
monoclonal
antibody
Type of Product
$23.6
$1,574.0
$554.6
2004 US Sales
($US, in MM)
NHL
Follicular NHL
Metastatic
Colorectal
Tumor-type
$52,250
Avastin
®
$59,080
Rituxan
®
$60,000
Zevalin
®
Average Price per
year or treatment
course
($US)
Biotechnology cancer therapies command a premium price in today’s
market


9
BiovaxID pricing will reflect multiple market inputs
Phase 2 trial data indicates that BiovaxID results in longer disease free
survival than the current most widely used therapy
Phase 2 trial data indicates that BiovaxID has fewer side-effects than
passive immunotherapies
BiovaxID targets only cancerous B lymphocytes
No immunosuppression
Only immunotherapy shown in a peer reviewed publication
to induce molecular remission
BiovaxID is a single course therapy (no requirement for annual treatment)


10
B
cell
lymphoma
and
related
diseases
-
illustrative
analysis
of market
potential
$1.0 B
$0.8 B
$0.6 B
8,200
5%
$9.8 B
$8.2 B
$5.75 B
82,400
50%
$14.8 B
$12.3 B
$8.6 B
123,000
75%
$19.7 B
$16.4 B
$11.5 B
164,000
100%
$4.9 B
$4.1 B
$2.9 B
41,200
25%
$2.0 B
$1.6 B
$1.2 B
16,400
10%
$120,000
$100,000
$70,000
Implied Annual Market
Size For Various Treatment Costs
Implied patients
treated per year
Illustrative Market
Penetration
1.
Assumptions for illustrative purposes only
2.
Based on a total of 164,000 new cases of B cell lymphoma and related diseases per year.  NB launch indication is follicular lymphoma, total of 34,000 new patients per year
3.
For illustrative purposes only
1
2
3


11
BiovaxID complements current therapies for non-Hodgkin’s lymphoma
Debulk Tumor
Designed to kill residual tumor cells
Designed to provide ongoing
immunosurveillance for recurrent tumor
Chemotherapy
Monoclonal antibodies
(e.g. Rituxan)
Radiation therapy
Surgery
Use Patients Tumor Cells
to Produce BiovaxID
Administer BiovaxID
1
2
3
1
2
3


12
BiovaxID
works
by
stimulating
the
immune
system
to
destroy
tumor cells
but not normal cells
All NHL tumor cells have unique
markers on their surface
The human immune system
does not recognize these as
foreign
Thus the tumor cells can
proliferate
The unique  marker proteins
can be purified and modified to
make them look foreign to the
patients immune system to
generate a vaccine
The vaccine stimulates the
immune system to seek out and
destroy tumor cells and nothing
else
Tumor Biopsy
Vaccine Production –
create complete
idiotype antigen from
hybridomas
The idiotype (Id) of the
surface immunoglobulin
receptor is a clonal
marker –
truly tumor
specific
Vaccinate
patient


13
BiovaxID –
vs.
other NHL therapies
Compared to other autologous (patient specific) active immunotherapies for NHL
Only therapy using a complete copy of patient’s own target antigen
Only
therapy
using
true
monoclonal
antibody
technology
no
molecular
splicing
needed to
make vaccine
Only therapy with peer-reviewed publication of complete phase 2 trial data
Longest follow-up of phase 2 patients
Only therapy being co-developed with National Cancer Institute
Compared to non-specific passive immunotherapies
Long-term active immunity against cancer vs. transient benefit of passive therapies
Only targets cancerous B cells
No clinical complications related to immunosuppression
No radioactive substances required (eg Bexxar, Zevalin)
Compared to chemotherapy
BiovaxID complements standard chemotherapy regimens
Future testing will focus on BiovaxID replacement of chemotherapy
Benefits of replacement will include elimination of unwanted chemotherapy side-effects and
reduced time and cost of total therapeutic regimen


14
Biovest’s new AutovaxID cell culture instrument will ensure that
BiovaxID manufacturing will be scalable and cost effective
Biovest’s automated
AutovaxID-C
bioreactor with its
patient-specific
cartridge, produces
idiotype protein,
the core of the
BiovaxID cancer vaccine


15
The AutovaxID-C™
can be set up in minutes.
Control unit
Disposable culture
module
Refrigerated product storage
Introducing cells
Bar code ID scan
Programming
Mounting culture
module in control
unit


16
BiovaxID: Near-Term Milestones
2006
2006
2007
2007
Pursue fast track designation
Open clinical sites in Russia and EU
Complete design phase of commercial
BiovaxID facility
Double size of vaccine manufacturing facility
Complete enrollment in trial
AutovaxID-C instruments clinical trial
2007 DSMB review


17
AutovaxID


18
Biovest Advanced Instrumentation Division
AutovaxID-C
The culmination of over 15 years of
development at Biovest
Currently installed and operating at
Biovest
Earlier Biovest instruments currently
being used by over 100 companies
worldwide
AutovaxID-C
Early Biovest cell
culture instruments
20 years of leadership in the design and manufacture
of innovative automated cell culture instruments


19
AutovaxID-C -
enabling the scalable production of cells and cell products
The AutovaxID-C -
the only automated
cell culture instrument available
Automated instrument –
no manual
transfers or manipulations
Minimal contamination risk–
cell growth
takes place in sealed sterile patient-
specific modules.
Reduces manufacturing failures
Minimizes error
Dozens of AutovaxID-C instruments can
operate side by side in a compact space
monitored by minimal staff
Uses flasks or bottles (shown here) to grow
cells
Many labor-intensive manual manipulations
and transfers
Significant risk of contamination
Manual cell culture


20
Biovest conducted a nation-wide market survey of potential users of the
AutovaxID-C
Seventy respondents participated in the survey, representing 29
commercial companies (biotech/pharma/contract manufacturing) and
41 university-based centers
With only a brief introduction to the instrument 50% of respondents
indicated a desire to acquire one or more AutovaxID-Cs
AutovaxID-C features identified by potential users as having a high
value include:
Antibody output
Automation
Ease of use
Size (space savings)
Self containment (limits need for costly clean room space)
AutovaxID-C : strong market feedback
Survey conducted by


21
Organizations expected to use AutovaxID-C instruments number over 500
in the US alone
Instrument sales revenue will be complemented by recurring revenue for
the disposable single-use AutovaxID-C cell growth cartridges
Additional sources of revenue include pre-filled growth media containers,
service, and custom growth cartridges
Key enabling technology for the emerging field of personalized medicine
Total market for AutovaxID-C and consumables estimated at $120MM in US
Comparably sized market estimated to be available in Europe
Market expected to grow with increasing use of personalized medicine
AutovaxID-C offers the opportunity of revenues in 2006/2007


22
AutovaxID-C:  Near-Term Milestones
2006
2006
2007
2007
Get FDA clearance to market    
Install AutovaxID-C in beta test sites
Finalize sales and distribution
Begin commercial manufacture AutovaxID-C
Begin commercial sales of AutovaxID-C
Incorporate AutovaxID-C into clinical trial
AutovaxID-C roll out at scientific meetings
Delivery
of commercial AutovaxID-C units


23
Financials


24
Biovest International, Inc. (Historical)
2001
2002
2003
2004
2005
Revenues
Cell culture products and services
5,241
5,293
2,192
2,145
1,137
National cell culture center
1,183
1,285
1,255
1,107
894
Instruments and disposables
3,672
4,701
4,809
2,454
3,046
Total revenues
10,096
11,279
8,256
5,706
5,077
Operating costs and expenses:
Cost of sales
7,384
8,691
6,283
5,447
3,750
Research and development
2,673
2,260
2,591
5,541
9,950
Marketing, general and administrative
5,667
4,166
4,939
3,251
2,438
Total operating costs
15,724
15,117
13,813
14,239
16,138
Loss from operations
(5,628)
(3,838)
(5,557)
(8,533)
(11,061)
Interest expense
(204)
(362)
(498)
(463)
(418)
Net loss
(5,832)
(4,200)
(6,055)
(8,996)
(11,479)
Biovest International, Inc.
Statements of Income
Fiscal Years ended September 30


25
AutovaxID business model
2007
2008
2009
2010
2011
2012
Revenues:
Autovax instrument and disposables,
4,000
           
21,000
            
43,000
            
72,000
          
114,000
        
163,000
        
net of distributor discounts
4,000
           
21,000
            
43,000
            
72,000
          
114,000
        
163,000
        
Operating costs and expenses:
Cost of sales - Autovax
3,000
           
12,000
            
22,000
            
33,000
          
51,000
          
70,000
          
G & A - Autovax
1,000
           
2,000
              
2,000
              
2,000
           
2,000
           
2,000
           
Total operating costs and expenses
4,000
           
14,000
            
24,000
            
35,000
          
53,000
          
72,000
          
Interest expense - Autovax plant
1,000
           
1,000
              
1,000
              
1,000
           
1,000
           
1,000
           
Net income (loss)
(1,000)
          
6,000
              
18,000
            
36,000
          
60,000
          
90,000
          
Projected Fiscal Years Ended
Biovest International, Inc.
Proforma Statements of Operations-Autovax Division
(Amounts in $,000)


26
BiovaxID-FL business model
2006
2007
2008
2009
2010
2011
2012
Revenues:
BiovaxID FL
-
             
-
             
-
             
-
             
350,000
      
700,000
      
700,000
      
-
             
-
             
-
             
-
             
350,000
      
700,000
      
700,000
      
Operating costs and expenses:
Cost of sales - BiovaxID
-
             
-
             
-
             
-
             
80,500
        
147,000
      
147,000
      
Research and Development - BiovaxID trial
10,502
        
27,000
        
27,000
        
3,000
          
-
             
-
             
-
             
G & A - corporate, legacy and clinical trials
3,355
          
7,000
          
7,000
          
2,000
          
2,000
          
2,000
          
2,000
          
Total operating costs and expenses
13,857
        
34,000
        
34,000
        
5,000
          
82,500
        
149,000
      
149,000
      
Interest expense - convertible debt
1,000
          
6,000
          
6,000
          
6,000
          
6,000
          
6,000
          
6,000
          
Net income (loss)
(14,857)
       
(40,000)
       
(40,000)
       
(11,000)
       
261,500
      
545,000
      
545,000
      
Projected Fiscal Years Ended
Biovest International, Inc.
Proforma Statements of Operations-BiovaxID Division
(Amounts in $,000)


27
Consolidated business model
2006
2007
2008
2009
2010
2011
2012
Revenues:
Legacy instrument and disposables
6,000
                 
3,000
                 
3,000
                 
3,000
              
3,000
           
3,000
           
3,000
           
Autovax instrument and disposables, net
-
                    
4,000
                 
21,000
              
43,000
            
72,000
          
114,000
        
163,000
        
BiovaxID-FL
-
                    
-
                    
-
                    
-
                  
350,000
        
700,000
        
700,000
        
6,000
                
7,000
                
24,000
              
46,000
            
425,000
        
817,000
        
866,000
        
Operating costs and expenses:
Cost of sales - legacy products
3,744
                 
2,000
                 
1,000
                 
2,000
              
2,000
           
2,000
           
2,000
           
Cost of sales - Autovax
-
                    
3,000
                 
12,000
              
22,000
            
33,000
          
51,000
          
70,000
          
Cost of sales - BiovaxID-FL
-
                    
-
                    
-
                    
-
                  
80,500
          
147,000
        
147,000
        
Research and Development - BiovaxID-FL trial
10,502
              
27,000
              
27,000
              
3,000
              
-
                
-
                
-
                
G & A - corporate, legacy and clinical trials
3,355
                 
7,000
                 
7,000
                 
2,000
              
2,000
           
2,000
           
2,000
           
G & A - Autovax
-
                    
1,000
                 
2,000
                 
2,000
              
2,000
           
2,000
           
2,000
           
Total operating costs and expenses
17,601
              
40,000
              
49,000
              
31,000
            
119,500
        
204,000
        
223,000
        
Interest expense - convertible debt
1,000
                 
6,000
                 
6,000
                 
6,000
              
6,000
           
6,000
           
6,000
           
Interest expense - Autovax plant
-
                    
1,000
                 
1,000
                 
1,000
              
1,000
           
1,000
           
1,000
           
Interest, other
504
                    
-
                    
-
                    
-
                  
-
                
-
                
-
                
1,504
                
7,000
                
7,000
                
7,000
              
7,000
           
7,000
           
7,000
           
Net income (loss)
(13,105)
             
(40,000)
             
(32,000)
             
8,000
              
298,500
        
606,000
        
636,000
        
Projected Fiscal Years Ended
Biovest International, Inc.
Proforma Statements of Operations-Consolidated
(Amounts in $,000)


28
Use of Proceeds
Clinical Costs for completion of enrollment of Phase 3 trial
CHOP-R Arm
$12.3 MM
PACE Arm
$  4.1 MM
Vaccine Manufacturing
CHOP-R Arm 
$27.8 MM
PACE Arm
$  9.2 MM
AutovaxID commercial launch
$  2.0 MM
AutovaxID assembly plant
$  4.0 MM
Corporate management
$ 14.6 MM
of  current commercial products and clinical trial


29
Strategic Initiatives
BiovaxID
Partner with “large pharma”
for
Regional sales and distribution
Global sales and distribution
Additional clinical trials
AutovaxID
Sales and distribution partner
Manufacturing partner
Personalized medicine applications development
Development partnerships to expand AutovaxID line
Biovest
Pipeline development
Separate therapeutics and instrumentation divisions into individual companies
Possible divestiture of either division if merited


30
Appendix
and
additional materials


31
Biovest Facilities
Facilities:
Worcester, MA: GMP vaccine
development and manufacturing center
Minneapolis, MN: engineering and
instrument development center
Commercial vaccine manufacturing
facility completion projected in 2008
Staff:
80  employees in Worcester, MA and
Minneapolis, MN


32
BiovaxID –
selected competitive therapies
Radioactive monoclonal antibody
Monoclonal antibody  from cultured cells
On market
Bexxar
GSK-Corixa
Radioactive monoclonal antibody
Monoclonal antibody  from cultured cells
On market
Zevalin
Biogen-IDEC
Monoclonal antibody
Monoclonal antibody  from cultured cells
On market
Rituxan
Biogen-IDEC
Type of antibody/drug
Manufacturing approach
Testing
status
Product
name
Company
Synthetic antibody -
DNA splicing
Produced by cultured insect cells
Phase 3
FavID
Favrille
Synthetic antibody  -
DNA splicing
Produced by cultured mouse cells
Phase 3
MyVax
Genitope
Monoclonal antibody vaccine –
complete
copy of patient’s surface antigen
Monoclonal antibody –
exclusive license from
Stanford for hybridoma technology
Phase 3
BiovaxID
Biovest
Type of antibody/drug
Manufacturing approach
Testing
status
Product
name
Company
Autologous “active”
immunotherapies
Non-specific “passive”
immunotherapies


33
Autologous immunotherapies for NHL:  positive  results from multiple phase
2 trials and clinical studies
Phase 2 study
(R induction)
Peer review clinical study
(various induction
therapies)
Phase 2 study
(CVP induction)
Phase 2 study
(PACE induction)
Peer review clinical study
(various induction
therapies)
Type of study
5
4
3
2
1
Ref. #
21
Genitope
Recombinant Id-KLH
Two centers
(Stanford, Nebraska)
Genitope (2001)
# of
patients
Sponsor
Type of antigen
Type of trial
Author/Sponso
r
103
Favrille
Id-KHL (recombinant)
Multi-
Center
Favrille (2004)
25
Stanford Univ.
Dendritic cells pulsed
with Id-KLH
(monoclonal).
Single Center
(Stanford Univ.)
Timmerman et al
2002
20
NCI/Biovest
Id-KLH (monoclonal)
Single Center (NIH)
Bendandi et al
1999
41
Stanford Univ.
Id-KLH (monoclonal)
Single center trial
(Stanford Univ.)
Hsu et al, 1997
The BiovaxID approach to treating NHL using autologous idiotype monoclonal antibodies (lines 1 and 2)
was the first successful application of antibody therapy to NHL
BiovaxID phase 2 trial and follow-up data was the impetus for the development of the field of
autologous NHL therapy
BiovaxID follow-up data provide support safety and efficacy of therapy
1.
Hsu et al, Blood 1997; 89:3129
4. Timmerman JM et al, Blood 2002; 99:1517
2.
Bendandi M, et al Nature Medicine 1999; 10:1171
5. Favrille reports and ASH 2004.
3.
Genitope reports and ASH 2001.
Studies using
the BiovaxID
approach
Studies using
alternative
approaches
Over 200 patients treated in clinical studies using Id-KLH for treatment of indolent –
NHL


34
BiovaxID phase 2 trial data –
comparative analysis
75-94%
Varies
Not
applicable
Not
applicable
58-88%
after 5
years
Various
Various
Yes
R-CHOP
Not
reported
Not
reported
Not
reported
Not
reported
Not
reported
66% after
1.5 yr
Not
available
No
Favrille
FavID
Not
reported
Not
reported
48%
44%
Not
reported
48% after
4-6 yr
3.1 yr
No
Genitope
MyVax
90%
73%
75%
95%
95% after
8-10 yr
45% after
8-10 yr
8.1 yr
Yes
Biovest
BiovaxID
Overall
clinical
response
% with
molecular
emission
% with
humoral
immune
response
% with
cellular
immune
response
Overall
survival
%
remaining
in CR
Median
DFS
Data
published


35
BiovaxID -
only autologous therapy for NHL shown to induce both clinical and
molecular remissions in patients
NCI/Biovest Phase II study in 20 patients
with long-term follow-up
At 9.1 years median follow-up: 95% alive
and 45% tumor free¹
Historical comparison: 50% alive and 0%
tumor free
73% of treated patients remained in
molecular remisison at the latest time their
samples were analyzed (median follow-up of
18 months)
Excellent adverse event profile; no negative
impact on patient quality-of-life
8.0
2.2
6.9
0
1
2
3
4
5
6
7
8
9
BiovaxID
NCI study
(ProMACE
CytaBOM)
CHOP-R
CHOP-R³
(current
widely used
therapy)
BiovaxID¹
NCI
study²
1.
Santos et al (2005) Abstract #645, ASH Annual Meeting
2.
Neelapu et al (2005) Clin. Lymphoma, ^, 61-64
3.
Czuczman et al, (2004) J Clin Oncol, 22, 11-47
BiovaxID Phase 2 median disease free survival surpasses most widely used
current therapy


36
Biovest Phase 3 Trial Summary
Objectives
Primary
To determine the impact of Id immunization on clinical disease-free
survival (DFS) of FL patients achieving a CR with standard dose
chemotherapy.
Secondary
To determine the ability of Id vaccine to produce a molecular CR
in-subjects
in clinical CR, but with PCR evidence of residual disease after standard
chemotherapy.
To determine the impact of Id immunization on molecular DFS in FL
subjects.
To evaluate the ability of Id vaccine to generate an immunology response
against autologous tumor.
To determine and compare the overall survival of subjects randomized to
receive either treatment assignment.
To evaluate the safety of a series of five immunization injections
administered with GM-CSF as adjunct therapy over a 6 month period.


37
Biovest Phase 3 Trial Summary
460 patients need to be enrolled (Segment A)
375
patients
to
be
randomized (Segment B)
250 patients will be randomized to active
immunization group, 125 to placebo group
As of July 2006:
210 patients enrolled in segment A (PACE)
162 patients enrolled in segment B (vaccine or
control)


38
Biovest Phase 3 Trial Summary-
Statistics
The phase 3 trial is powered according to the following assumptions:
The median disease-free survival for subjects with follicular
lymphoma treated with GM-CSF alone is expected to be 3.5 years.
Sample size calculations were performed based on simulations
assuming an intent to treat analysis, equal hazards (1.0 hazard
ratio) for the first 8 months (when treatments are expected to be
the same in both randomized arms), and then a hazard ratio of 2.0
after 8 months
Enrollment numbers calculated to allow approximately 80.4% power
to detect a difference between disease-free survival curves
A two-sided hypothesis test at the alpha=0.01 level will be used to
ensure a stringent evaluation.


39
Biovest Phase 3 Trial Summary-
Statistics
The DSMB conducts annual interim analyses of efficacy
Annual
interim
evaluations
will
be
done
by
the
DSMB
to
determine
whether there
is sufficient evidence to terminate accrual because of a better than expected
improvement in disease-free survival
An alpha spending function approach to monitoring is done using an O'Brien-
Fleming boundary.  It is assumed that a total of 225 subjects would progress
over a maximum of 8 years of monitoring. The information fraction used to
compute the interim boundary at each annual evaluation will be calculated as the
number of subjects progressed divided by 225.
The information fraction at each annual evaluation is used to determine the alpha
value at that time point as shown below


40
AutovaxID-C  provides Biovest with a competitive edge in the
manufacture of BiovaxID
Large labor force
needed
Isolation requirements for manual
process means large facilities
Need for costly procedure rooms with
sophisticated air handling systems
Material and process tracking via
manual entry
in numerous records and
forms –
paper batch record
generated
Multiple culture transfers between
flasks
increases possibility of
contamination
Efficient use of manpower
Sealed growth modules mean
compact facilities
Minimal need for costly facility air
handling systems
Automated electronic batch
record generated
Sealed sterile culture module
eliminates possibility of
contamination.
Manual
cell culture
AutovaxID-C
cell culture
AutovaxID-C is a reliable and cost-effective
Improvement on traditional cell culture techniques


41
Biovest background and recent developments
2005: Balance sheet simplified through elimination of $5.5 MM debt and reduction of
outstanding warrants and convertible rights to equity
2005:  Approximately 510 shareholders of record (December, 2005)
2005:
Commenced
public
trading
on
OTC
Bulletin
Board
(BVTI.OB)
-
August
2005: Transfer of all vaccine manufacturing to Worcester facility
2004: Took over NHL clinical trial from NCI
2003: Accentia acquires 81% ownership of Biovest
2001: Awarded Cooperative Research and Development Agreement with NCI for
commercialization of NHL vaccine therapy
2000: Chosen as contract manufacturer for NCI cancer vaccine
Company
formed
through
merger
of
Cellex
and
Unisyn
instrumentation
and GMP
manufacture
of
biologics
over
20
years
in
the
cell
culture
instrumentation business
SEC registrant since mid-1983


42
BioVest capital structure -
uncomplicated
Authorized Capital Stock:
Common:
300,000,000 shares $0.01 par 
Preferred:
50,000,000 shares $0.01 par
Outstanding Capital Stock:
Common:
70,626,635 shares issued
Preferred:
Zero Preferred shares outstanding
Fully Diluted:
Options:
6,366,141
Warrants:
20,287,889
Convertible Rights:
136,687
Accentia First Right of Refusal
3,481,034
As of June 30, 2006
As of June 30, 2006
1.
Plan increase to 20 million options to  be recommended for approval at September 20, 2006 Shareholders
meeting.
2.
$136K convertible notes being paid monthly
3.
Assumes Accentia exercises first right of refusal on warrants (on non-NMTC financing) and convertible rights
issuances; at 75.21% ownership
1
2
3


43
Biovest & Accentia relationship
* Accentia
has
specifically
waived
its
exercise
of
First
Right
of
Refusal
on
all
warrants issued
with respect to New Market Tax Credit financing.
100.00%
100.00%
100,898,386
Total Fully Diluted
44.45%
24.79%
44,852,214
Total Ownership by others
27.10%
27,341,397
Exercisable Options, warrants, and convertible notes
17.35%
24.79%
17,510,817
Common stock issued
Others
55.55%
75.21%
56,046,172
Total Accentia Ownership
2.90%
2,930,354
FRR exercise potential
52.64%
75.21%
53,115,818
Common stock issued
Accentia:
Fully Diluted
Primary 
Common
Shares
Biovest Ownership June 30, 2006
Ownership Percentage