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Immu Med

A Therapeutic Antibody Company Corporate Overview August 2013

Private and Confidential

Immu Med

Inc.© 2013

Confidential

Immu

Med

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

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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

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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” Immu

Med 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

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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) –

Multiple antigenic sites – cytotoxic activity None approved for prevention of rejection

95% US Revenue Share

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

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2012 Global Antibody Sales

Approved Polyclonal & Monoclonal Antibodies

Product Name Type of Product Manufacturer Indication $$ Sales ($Millions) % Change vs. PY Thymoglobulin

®

(Rabbit) Polyclonal Genzyme Simulect

®

(Murine) Monoclonal Novartis Rx AR Induction $320 $110 12.0 % 4.5 % rATG * (Rabbit) Polyclonal * Not sold in U.S.

Source: Evaluate Pharma 2013

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Rx AR $ 40 8.0 % 7

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

**

R&D PC Program Indication Biological Antibodies ALG Solid Organ Transplantation IATG-BMT Bone Marrow Transplantation H. anti HIV ISI Mab Adjuvant Therapy in HIV and AIDS Recombinant Antibodies Infectious Diseases Cancer Immunotherapy Additional Opportunities Phase I Phase II Phase III ** Of products in its portfolio,

Immu Med

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

Human Studies Phase I (1) Phase II (2) Phase III (3) Published Scientific Studies Sample Size Pharmacokinetics (N = 104) Dose response in humans a) Skin grafts (N = 102) b) Renal grafts (N = 47) Major Findings Depletion Circulating lymphocytes Increased graft survival was dose related Study drug v. Placebo Renal grafts (N = 160) 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 Efficacy Graft Survival: 1 year Graft Survival: 3 years First rejection episode (median) ALG (n=81) 48/81 (59%) 45/81 (56%) 28 days Albumin (n=79) P-Value 37/79 (47%) 18/79 (23%) 11 days p = 0.02

p<0.015

p<0.0001

Safety Fever Chills Hematuria Nausea Infections 24.7% 13.6% 11.1% 7.4% 49.4% 15.2% 6.3% 13.9% 2.5% 55.7% NS NS NS NS NS

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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 % Graft Survival 6 months 12 months % Patients with Rejection 12 months Serum Creatinine (mean) 6 months 12 months rATG (n=50) 98+1.98 96+2.77

83.9+5.2 81.7+5.5

60 (30) 1.90+1.6

1.91+.22

ALG (n=48) 95.8+2.9 95.8+2.9

p value NS NS 87.5+4.8

84.6+5.4

50 (24) 1.87+.13

1.72+.07

NS NS NS NS NS

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IALG: Favorable Sample Size and AE/SAE Rates Renal Transplant Patients

Safety Database ALG (1) 8,059 Atgam (2) 1,587 OKT3 (2) 63 Thymoglobulin (2) Simulect (2) 82 193 Incidence of Death

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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.

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Proven Polyclonal Market (Thymoglobulin)

Sales and Market valuation of Thymoglobulin have soared due to:

$

600M 2003

Q3 – Genzyme

Acquires Sangstat

Off-label use

Absence of competitors $31M 1998

Q4 – Sangstat

Acquires Thymoglobulin From Pasteur Merioux: 2012 $320 M History 1980 1993 Sangstat (California) Licensed Lymphoglobuline, N.A.

Renames: Thymoglobulin Pasteur Merioux (France) 1993 Product: Lymphoglobuline in EU 1997

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 18.7% 2003 $91M 18.5% 2004 $108M 11.5% 21.9% 2005 $128M 2006 $156M

17.8%

2007 $168M

17.2%

2008 $198M Sales 7.1% 2009 $232M 2010 $250M ** Sales to 2010 derived from 10Q filings; since Sanofi purchase current sales (2012) independent estimate

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IALG Competitive Advantages

IALG Thymoglobulin Immu Med

Sanofi

1 Horse = 140 liters Large Plasma Inventory Liquid Solution Always High B-Cell 99% <1%

Immu Med

Inc.© 2013 T-Cell Production Efficiency Mfg. Volumes Physical State Market Factors Gross Margins Safety & Efficacy Antigen Type Purity Micro-aggregates

Confidential

2,800 Rabbits = 140 liters Low Inventory Potential Powder-Freeze Dried Fraction of MALG T-Cell Only 90% 10%

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Strong Intellectual Property

IALG ADVANTAGE Proprietary Essential to Developing Biologic Activity Patentable 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

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Multiple Registration Plans Available for IALG

   

Pivotal Trial Options Available

US Trial Potentials

NIT to Standard of Care Label Induction Label NIT to Simulect or Zenapax Superiority to Simulect or Zenapax NIT to Atgam or Thymoglobulin Differential Dosing (high/low IALG dose) Induction Label Induction Label Rejection Treatment 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, Immu Med

• • • • • •

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

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IALG Revenue Model IALG Pro Forma vs. Expected Global Market

(5% Projected Growth) Pro Forma Global

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600.0

Funding 533.0

587.6

647.8

500.0

400.0

300.0

200.0

100.0

0.0

19.3

1992 97.2

2003 470.0

0.0

2012 27.3

2014 Year 83.9

2016 246.8

2018 Confidential

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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

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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:

Material Build the ImmuMed Company Restart IALG Production O U T S O U R C E Prod Testing Trials FDA Phase III IND IALG #1 Sales Strategic Alliances for Distribution R&D Outsourcing Co-Develop IPO Acquired Merge

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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.

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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.

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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.

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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

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Inc.© 2013

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