ImmuMed
A Therapeutic Antibody Company
Corporate Overview
August 2013
Private and Confidential
ImmuMed Inc.© 2013
Confidential
ImmuMed Profile

Private therapeutic antibody company

Mission: To utilize our proprietary therapeutic antibody platform
and build a leading organ transplantation business and transform
the field by expanding recipient eligibility and enabling universal
organ donor transplants

Established Lead product: Anti-Lymphocyte Globulin (ALG)
– Historical use in 52,000 in organ transplant recipients at over 281
transplant centers across the U.S., Canada and parts of Europe
– Primary indication: Induction Therapy (Prevention of Acute Rejection)
– Published scientific record of efficacy and safety, support from KOLs in
transplant

Antibody Platform and Pipeline Portfolio targeting antibody markets
> $3B
ImmuMed Inc.© 2013
Confidential
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Investment Thesis – ROI vs R&D process
mitigates risk

Initial transplant antibody market size estimated at $470M W/W
- 85% of revenue earned from Induction Therapy **

Opportunity to revive proven product used in over 52,000 patients
– Task: update mfg. and reproduce historical tox data to satisfy FDA
IND requirement

$30M investment to market-rollout first product
– $10M to kick-off Ph III and potential IPO

Projected $250M+ in revenue within 5 years

Competitor with $79M in revenue sold for $600M in 2003 (8X multiple)

Additional revenue from pipeline development funded by product sales
** Induction Therapy is a drug protocol employing the administration of therapeutic
antibodies to prevent rejection immediately following organ transplantation
ImmuMed Inc.© 2013
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Market Value Proposition

Growing organ transplantation industry
– Increasing demand for organ transplants (W/W)
– Global Shortage of Donor Organs (growing waiting lists)
– Increasing Use of High-Risk Donor Organs (must use polyclonal antibody)

Fragmented market without a clear leader
– Multiple products are sold into the field on a fragmented basis

Clear unmet transplantation medical need
– No product enables universal organ donation
– No polyclonal antibody currently licensed for induction therapy
– No product addresses sensitized recipients
– Key anti-rejection products are marginally effective or sold “off-label”

ImmuMed well positioned for:
– Market expansion by enabling universal organ transplants
– Capture the sales of current products now being used off-label
– Consolidation of existing products and businesses
– Market leadership to Establish Induction Therapy as Standard of Care
ImmuMed Inc.© 2013
Confidential
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Competitive Landscape for Induction Therapy
Antibody-based Immunosuppressive Drugs

Monoclonal Antibodies (Low Risk Recipients)
5% US Revenue Share
– Single antigenic site with high specificity
– Two (Simulect,® Zenapax®) approved to prevent rejection
– One (OKT3) approved to treat acute rejection

Polyclonal Antibodies (High Risk Recipients)
95% US Revenue Share
- Multiple antigenic sites – cytotoxic activity
– None approved for prevention of rejection
– Two approved (Thymoglobulin® , Atgam®) to treat acute rejection
– Treatment of Acute Rejection by antibodies – occurs in 4% of transplants
– Antibody revenues (Induction Therapy) now driven by Off-Label Use
– See IALG advantages vs. Thymoglobulin
– More efficient production at higher margins
– Absence of 10% microaggregates  less safety concerns
ImmuMed Inc.© 2013
Confidential
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2012 Global Antibody Sales
Approved Polyclonal & Monoclonal Antibodies
Product Name
Thymoglobulin®
(Rabbit)
Type of
Product
Polyclonal
Manufacturer
Genzyme
Indication
$$ Sales
($Millions)
% Change
vs. PY
Rx AR
$320
12.0 %
Simulect®
(Murine)
Monoclonal
Novartis
Induction
$110
4.5 %
rATG *
(Rabbit)
Polyclonal
Fresenius
Rx AR
$ 40
8.0 %
* Not sold in U.S.
Source: Evaluate Pharma 2013
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Technology Background
• Therapeutic antibody technology acquired from U. Minnesota 1996
•
$66M R&D investment already done
• Lead product: ImmuMed Anti-Lymphocyte Globulin (“IALG”)
•
Primary indication: prevent rejection after solid organ transplantation
•
52,000 patient administrations (Compassionate Use) at least 281 transplant
centers across the U.S., Canada and parts of Europe
Lack of sufficient data reporting on compassionate use caused FDA clinical hold
University refused commercial drug production
FDA issue with original inventor resolved
•
•
•
• Multiple pipeline products from common plasma inventory
•
•
•
•
Precondition donor tissue for bone marrow and stem cell transplants
Aplastic anemia
Autoimmune diseases
Lymphomas (FAB2 form)
• Qualified strategic partners identified
•
•
•
•
CMO: Cangene and/or Therapure BioPharmaceutical
CSO: Bio-Reliance and Apptec
CSO: Lake Immunogenics
CRO: Cato Research; Kendle; CTI
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Pipeline
Common Manufacturing Platform
PRODUCT PIPELINE
Program
Indication
R&D
PC
**
Phase I
Phase II
Phase III
Biological Antibodies
ALG
Solid Organ Transplantation
IATG-BMT
Bone Marrow Transplantation
H. anti HIV
Adjuvant Therapy in HIV and AIDS
Recombinant Antibodies
Fab2
Infectious Diseases
ISI Mab
Cancer Immunotherapy
Additional Opportunities
** Of products in its portfolio, ImmuMed has prioritized the sequence in which to develop
acquired compounds based on the current stage of clinical development listed below.
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Pipeline Target Markets
• Lead product: ImmuMed Anti-Lymphocyte Globulin (“IALG”)
•
$470MM potential market oppty. based on existing drugs
• Target markets for follow on pipeline products (derivatives
of common plasma inventory = truncated development
pathway)
• Graft versus Host disease in Bone Marrow Transplant ($80MM)
• Aplastic Anemia ($175MM)
• Reduced viral loads in CMV and HIV infected patients ($750MM)
• B-cell lymphoma ($30MM)
• B-Cell Mediated Auto-Immune Diseases ($125MM)
• IVIG ($1.4B)
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How Does IALG Work?
- Adjuvant Immunosuppressive Drug
Adjuvant = administration as add-on to background immunosuppressive
regimens to improve outcomes
- Mechanism of Action
Cytotoxic to lymphocytes (including those causing acute organ rejection )
Decreases: Recognition of Foreign Antigen
Incidence of Acute Rejection
Incidenceof Post-op dialysis events
- Degraded by Liver
• Anti-IALG antibodies occasionally measured
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Clinical Development Summary
Published Scientific Studies
Human Studies
Sample Size
Major Findings
Phase I (1)
Pharmacokinetics
(N = 104)
Depletion Circulating
lymphocytes
Dose response in humans
Phase II (2)
a) Skin grafts (N = 102)
b) Renal grafts (N = 47)
Phase III
(3)
Study drug v. Placebo
Renal grafts (N = 160)
Increased graft survival
was dose related
Therapeutic Benefit
improved renal graft
survival at 1 & 3 years
** No Safety Issues **
1) Buchman TE., et al; Transplantation. 55(5):1190-3, 1993 May.
2) Simmons RL. Moberg AW., et al: Surgery. 68(1):62-8, 1970 Jul.
3) Condie RM, et al, Transplantation proceeding 1985; XVII(1): 1304-1311.
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Phase III Trial Efficacy: Enhanced Graft
Survival
ALG versus Placebo (Phase III study)
Multicenter Efficacy Study for Induction Therapy
Post-Transplant Event
ALG (n=81)
Albumin (n=79) P-Value
Efficacy
Graft Survival: 1 year
48/81 (59%)
37/79 (47%)
p = 0.02
Graft Survival: 3 years
45/81 (56%)
18/79 (23%)
p<0.015
First rejection episode (median)
28 days
11 days
24.7%
13.6%
11.1%
7.4%
49.4%
15.2%
6.3%
13.9%
2.5%
55.7%
p<0.0001
Safety
Fever
Chills
Hematuria
Nausea
Infections
ImmuMed Inc.© 2013
Confidential
NS
NS
NS
NS
NS
13
Comparative Performance Equine vs. Rabbit
IALG vs. Rabbit Antithymocyte Globulin
[Comparative Efficacy for Induction Immunosuppression]
Univ Hospital of Cincinnati Cincinnati, OH + 4 other hospitals
% Patient Survival
6 months
12 months
rATG
(n=50)
ALG
(n=48)
p value
98+1.98
96+2.77
95.8+2.9
95.8+2.9
NS
NS
% Graft Survival
6 months
12 months
83.9+5.2
81.7+5.5
87.5+4.8
84.6+5.4
NS
NS
% Patients with Rejection
12 months
60 (30)
50 (24)
NS
Serum Creatinine (mean)
6 months
12 months
1.90+1.6
1.91+.22
1.87+.13
1.72+.07
NS
NS
ImmuMed Inc.© 2013
Confidential
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IALG: Favorable Sample Size and AE/SAE Rates
Renal Transplant Patients
ALG(1)
Atgam(2)
OKT3(2)
Thymoglobulin(2)
Simulect(2)
Safety Database
8,059
1,587
63
82
193
Incidence of Death
0.5%
28.0%
4.7%
7.3%
4.6%
(1) ALG data derived from all of the Case Report Forms submitted by transplant centers utilizing ALG in response
to a letter request from the University of Minnesota pursuant to the clinical hold imposed by FDA. They
represent data from all of the renal transplant patients from December 28, 1988 to August 12, 1992.
(2) Data from FDA’s summary basis of approval.
ImmuMed Inc.© 2013
Confidential
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Proven Polyclonal Market (Thymoglobulin)
 Sales and Market valuation of
Thymoglobulin have soared due to:

Off-label use

Absence of competitors
1993
History
1993
1998
Sangstat (California)
Licensed Lymphoglobuline, N.A.
Renames: Thymoglobulin
Pasteur Merioux (France)
Product: Lymphoglobuline in EU
18.7%
2003
$91M
ImmuMed Inc.© 2013
17.8%
11.5%
21.9%
2012
$320 M
Q4 – Sangstat
Acquires Thymoglobulin
From Pasteur Merioux:
Q1 – Sangstat Secondary Offering
@ $30 share, 2.6 M shares
H&Q lead, others
Q3 – Sangstat IPO
@ $7.50 per share
Piper lead, H&Q, others
18.5%
1980
2003
$31M
1997
Q3 – Genzyme
Acquires Sangstat
$600M
2006
$156M
17.2%
7.1%
2009
$232M
2010
$250M
2008
$198M
2007
$168M
Sales
2005
$128M
2004
$108M
** Sales to 2010 derived from 10Q filings; since Sanofi
purchase current sales (2012) independent estimate
Confidential
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IALG Competitive Advantages
IALG
Thymoglobulin
ImmuMed
Sanofi
Production
1 Horse = 140 liters
Efficiency
2,800 Rabbits = 140 liters
Large Plasma Inventory
Mfg. Volumes
Low Inventory Potential
Liquid Solution Always
Physical State
Powder-Freeze Dried
Market Factors
High
Gross Margins
Fraction of MALG
Safety & Efficacy
Antigen Type
T-Cell Only
99%
Purity
90%
<1%
Micro-aggregates
10%
B-Cell
T-Cell
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Strong Intellectual Property
IALG ADVANTAGE
Proprietary
Patentable
Essential to Developing
Biologic Activity
Essential to Not Destroying
Biologic Activity
Immunogens
T-cells
B-cell (available
only for IALG)
Newly Formulated
Plasma Purification
Process
Method of Immunization
Method of Lot Formulation
New Patent
Proprietary + Data + New Patent Claims = Unique Phase 3 Product
ImmuMed Inc.© 2013
Confidential
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Multiple Registration Plans Available for IALG
Pivotal Trial Options Available
US Trial Potentials
Label

NIT to Standard of Care
Induction Label

NIT to Simulect or Zenapax
Induction Label

Superiority to Simulect or Zenapax
Induction Label

NIT to Atgam or Thymoglobulin
Rejection Treatment

Differential Dosing (high/low IALG dose)
Induction Label
Non-US Trial Potentials

Study drug vs. Placebo; Induction Protocol

Superiority to Simulect or Zenapax

NIT to Simulect or Zenapax; Induction Protocol
Current Status:
No Approved Polyclonal Standard of Care for Induction
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FDA Pathway / Regulatory Milestones
Marketing approval for a large molecule biologic based on standardized
method of manufacturing correlated with safety and therapeutic
benefit data discovered pursuant to a pivotal clinical trial.
Based on Pre-IND Meetings, ImmuMed required to:
•
•
•
•
•
•
Finalize manufacturing method (finished by vendor)
Manufacture commercial size lots (sufficient for 2,400 patients)
Repeat toxicity study (required for new manufacturing process)
Submit new IND for IALG pivotal clinical trial (drafted)
Complete nested dosing and pivotal trial
File BLA using new acquired data
ImmuMed Inc.© 2013
Confidential
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IALG Revenue Model
IALG Pro Forma vs. Expected Global Market
(5% Projected Growth)
7 00 .0
6 47 .8
Funding
5 87 .6
Millions USD
6 00 .0
5 33 .0
4 70 .0
5 00 .0
4 00 .0
3 00 .0
2 46 .8
2 00 .0
9 7.2
1 00 .0
Pro Forma
1 9.3
0 .0
0 .0
Global
1 99 2
8 3.9
2 00 3
2 01 2
2 7.3
2 01 4
2 01 6
2 01 8
Ye ar
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Business Objectives

Complete Market Approvals for IALG
- Induction Therapy Indication
- Ph IV study for chronic rejection (3 and 5 year end-points)
- Expand life-cycle for desensitization therapy

Early Market Exposure and Revenues
- Secondary Retransplant Market in US – (≈ 2,000 / year)
- “Named-Patient” sales – EU and rest of world (ROW)
– Emergency drug release authorization (Canada)

Product Launches
 First on-label product in induction therapy(≈ 36 months)
 Capture “Off-Label sales; gain market share from monoclonals
 First product for desensitization (if studied)

Consolidate products/market as single industry leader
ImmuMed Inc.© 2013
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Business Model
Vision:
 Begin As Near Virtual Company during pre-revenue period
 Minimal Infrastructure, Rely On Outsourcing
 Avoid Amassing Overhead In Search of Products
 Focus On Achieving Early Cash Flow Projected 12 to 15 Months
 Commercialize Established Polyclonal Antibodies First
 No Early R & D Expense
 Build Infrastructure, R & D With Cash Flow

Expand Acquired Portfolio; In-License or Acquire New Technologies
Execution:
Build the
ImmuMed
Company
Restart
IALG
Production
ImmuMed Inc.© 2013
O
U
T
S
O
U
R
C
E
Material
Prod
Testing
FDA
Phase III
IND
IALG
#1
Sales
Trials
Confidential
Strategic
Alliances
for
Distribution
R&D
Outsourcing
Co-Develop
IPO
Acquired
Merge
23
Mitigation of Investment Risk
 Reduced Regulatory & Development Risk
–
–
–
–
–
–
–
Multiple, well-defined FDA pathways (5 previous antibody products)
No R & D required
absence of surprises, efficacy understood
52,000 patient history to supplement new safety data
Efficacy and superiority established
Data points (safety, dose, efficacy) to be replicated, not new
Manufacturing method establish/approved for another product type
Proven Mfg. partners with experience in existing products
 Attractive Commercial Opportunities
–
–
–
–
–
–
–
Growing transplant market
Product history demonstrates high medical approval
Acceptance of safety and efficacy profile
Multiple products derived from the same manufacturing platform
High manufacturing COG margins
Transplant market is mature, yet highly focused
Only few dozen leading US transplant centers potentiates “80:20” market
scenario.
ImmuMed Inc.© 2013
Confidential
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Executive Mgt.

Martin Driscoll, Chairman of the Board of Directors - Presently CEO and Director of
Asmacure Ltee, a venture-backed clinical-stage biopharmaceutical company. Previous CEO of
Javelin Pharmaceuticals (acquired by Hospira, Inc. in 2010). Over 31 years’ experience in bio
pharmaceutical industry with responsibility in commercial, business development, and general
management at Schering-Plough, ViroPharma, and Reliant Pharmaceuticals.

Allen Moberg, MD., Acting CEO/Director/CMO - Founder of ImmuMed, Inc.. Received his
MD degree in 1964 and thereafter was educated in general and transplantation surgery at the
University of Minnesota. Was responsible for development and patenting of medical devices for
organ preservation and cofounder of IALG Program with other colleagues in the University of
Minnesota’s Department of Surgery. Served as initial Program Director responsible for IALG’s
production, Phase I and Phase II clinical testing, coa-uthored IND. Recent focus on organizing
effort to return IALG to the marketplace, including raw material production and manufacturing
and regulatory affairs.

Thomas Burton, CFO/Director - Cofounder of ImmuMed. From 1960 to 1990, was President
and CEO of Waters Instruments, Inc., a diversified publicly traded company [ZRBA-NASDAQ]
manufacturing and marketing medical and electronic devices. Served by appointment by the
Governor of Minnesota on the Public Utilities Commission. Recently consulting with principal
investigators developing new products in the medical field.
ImmuMed Inc.
Confidential
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Advisors

Peter Levitch - Special expertise in clinical study design, implementation and compliance, good
manufacturing practices and regulatory affairs. 25 years as consultant to more than 200 biotech,
pharmaceutical and medical device companies, participating in at least 260 IND’s and FDA
approval of many biotechnology derived products. Previous Manager of Clinical Research at
Eaton Laboratories and Director of Clinical Research and Regulatory Affairs at Ortho Diagnostics,
where, acting as Responsible Head to CBER (working to assure compliance for Ortho’s 60
licensed products) and as Official Correspondent to CMDRH.

Thomas Stagnaro – Over 35 years’ experience in medical and biotechnology fields. Presently
President, CEO and Founder of Americas Biotech Distributor, LLC., distributing US biotech
products into Latin America. Previously President and CEO of Agile Therapeutics, Inc. Prior to
Agile, pharmaceutical consultant to Rock Hill Ventures/Hillman Medical Ventures, and President
and CEO of 3-Dimensional Pharmaceuticals, Inc. Former Senior Executive Vice President at NABI,
responsible for sales and marketing, generating sales in excess of $250 million and served as in
the research and development for human polyclonal antibody products and vaccines. At NABI,
managed the “In-licensing” of a late-stage product, and successfully brought the product through
CBER and launched in US. Prior to NABI, was President and CEO of Univax Biologics, Inc.,
(acquired by NABI in 1995 for $150 million).

John St. Cyr, II, MD, Ph.D. - Director of Research. Surgical education at University of
Minnesota, cardiovascular-thoracic training at University of Colorado Health Sciences, specializing
in adult and pediatric Cardiovascular surgery, and transplantation. History in research, dedicated
to myocardial preservation.
ImmuMed Inc.
Confidential
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Investment Thesis – ROI vs R&D process
mitigates risk

Initial transplant antibody market size estimated at $470M W/W
- 85% of revenue earned from Induction Therapy **

Opportunity to revive proven product used in over 52,000 patients
– Task: update mfg. and reproduce historical tox data to satisfy FDA
IND requirement

$30M investment to market-rollout first product
– $10M to kick-off Ph III and potential IPO

Projected $250M+ in revenue within 5 years

Competitor with $79M in revenue sold for $600M in 2003 (8X multiple)

Additional revenue from pipeline development funded by product sales
** Induction Therapy is a drug protocol employing the administration of therapeutic
antibodies to prevent rejection immediately following organ transplantation
ImmuMed Inc.© 2013
Confidential
27